Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients
Identifieur interne : 000E32 ( Pmc/Corpus ); précédent : 000E31; suivant : 000E33Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients
Auteurs : David N. Teguh ; René Bol Raap ; Henk Struikmans ; Cees Verhoef ; Linetta B. Koppert ; Arne Koole ; Yadi Huang ; Rob A. Van HulstSource :
- Radiation Oncology (London, England) [ 1748-717X ] ; 2016.
Abstract
This study examines patient reported outcome measures of women undergoing hyperbaric oxygen treatment (HBOT) after breast-conserving therapy.
Included were 57 women treated with HBOT for late radiation-induced tissue toxicity (LRITT) referred in the period January 2014-December 2015. HBOT consisted of (on average) 47 sessions. In total, 80 min of 100 % O2 was administered under increased pressure of 2.4 ATA. Quality of life was assessed before and after treatment using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23, and a NRS pain score.
Fifty-seven women were available for evaluation before and after treatment. Before HBOT, patients had severe complaints of pain in the arm/shoulder (46 %), swollen arm/hand (14 %), difficulty to raise arm or move it sideways (45 %), pain in the area of the affected breast (67 %), swollen area of the affected breast (45 %), oversensitivity of the affected breast (54 %), and skin problems on/in the area of the affected breast (32 %); post HBOT, severe complaints were still experienced in 17, 7, 22, 15, 13, 15, and 11 % of the women, respectively. Differences were all significant. The NRS pain score improved at least 1 point (range 0–10) in 81 % of the patients (
In these breast cancer patients treated with HBOT for LRITT, the patient-reported outcomes were positive and improvements were observed. HBOT was a well-tolerated treatment for LRITT and its side-effects were both minimal and reversible.
Url:
DOI: 10.1186/s13014-016-0700-0
PubMed: 27682427
PubMed Central: 5041335
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients</title><author><name sortKey="Teguh, David N" sort="Teguh, David N" uniqKey="Teguh D" first="David N." last="Teguh">David N. Teguh</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation><affiliation><nlm:aff id="Aff2">Department of Surgery/Hyperbaric Medicine, Academic Medical Center, University of Amsterdam, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Bol Raap, Rene" sort="Bol Raap, Rene" uniqKey="Bol Raap R" first="René" last="Bol Raap">René Bol Raap</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Struikmans, Henk" sort="Struikmans, Henk" uniqKey="Struikmans H" first="Henk" last="Struikmans">Henk Struikmans</name><affiliation><nlm:aff id="Aff3">Department of Radiation Oncology, Leiden University Medical Centre, Leiden, The Netherlands</nlm:aff></affiliation><affiliation><nlm:aff id="Aff4">Radiotherapy Centre West, Medical Centre Haaglanden, The Hague, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Verhoef, Cees" sort="Verhoef, Cees" uniqKey="Verhoef C" first="Cees" last="Verhoef">Cees Verhoef</name><affiliation><nlm:aff id="Aff5">Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Koppert, Linetta B" sort="Koppert, Linetta B" uniqKey="Koppert L" first="Linetta B." last="Koppert">Linetta B. Koppert</name><affiliation><nlm:aff id="Aff5">Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Koole, Arne" sort="Koole, Arne" uniqKey="Koole A" first="Arne" last="Koole">Arne Koole</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Huang, Yadi" sort="Huang, Yadi" uniqKey="Huang Y" first="Yadi" last="Huang">Yadi Huang</name><affiliation><nlm:aff id="Aff7">University of Leuven, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Van Hulst, Rob A" sort="Van Hulst, Rob A" uniqKey="Van Hulst R" first="Rob A." last="Van Hulst">Rob A. Van Hulst</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation><affiliation><nlm:aff id="Aff6">Department of Anesthesiology/Hyperbaric Medicine, Academic Medical Center, University of Amsterdam, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27682427</idno><idno type="pmc">5041335</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5041335</idno><idno type="RBID">PMC:5041335</idno><idno type="doi">10.1186/s13014-016-0700-0</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000E32</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000E32</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients</title><author><name sortKey="Teguh, David N" sort="Teguh, David N" uniqKey="Teguh D" first="David N." last="Teguh">David N. Teguh</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation><affiliation><nlm:aff id="Aff2">Department of Surgery/Hyperbaric Medicine, Academic Medical Center, University of Amsterdam, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Bol Raap, Rene" sort="Bol Raap, Rene" uniqKey="Bol Raap R" first="René" last="Bol Raap">René Bol Raap</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Struikmans, Henk" sort="Struikmans, Henk" uniqKey="Struikmans H" first="Henk" last="Struikmans">Henk Struikmans</name><affiliation><nlm:aff id="Aff3">Department of Radiation Oncology, Leiden University Medical Centre, Leiden, The Netherlands</nlm:aff></affiliation><affiliation><nlm:aff id="Aff4">Radiotherapy Centre West, Medical Centre Haaglanden, The Hague, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Verhoef, Cees" sort="Verhoef, Cees" uniqKey="Verhoef C" first="Cees" last="Verhoef">Cees Verhoef</name><affiliation><nlm:aff id="Aff5">Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Koppert, Linetta B" sort="Koppert, Linetta B" uniqKey="Koppert L" first="Linetta B." last="Koppert">Linetta B. Koppert</name><affiliation><nlm:aff id="Aff5">Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Koole, Arne" sort="Koole, Arne" uniqKey="Koole A" first="Arne" last="Koole">Arne Koole</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Huang, Yadi" sort="Huang, Yadi" uniqKey="Huang Y" first="Yadi" last="Huang">Yadi Huang</name><affiliation><nlm:aff id="Aff7">University of Leuven, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Van Hulst, Rob A" sort="Van Hulst, Rob A" uniqKey="Van Hulst R" first="Rob A." last="Van Hulst">Rob A. Van Hulst</name><affiliation><nlm:aff id="Aff1">Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation><affiliation><nlm:aff id="Aff6">Department of Anesthesiology/Hyperbaric Medicine, Academic Medical Center, University of Amsterdam, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</nlm:aff></affiliation></author></analytic><series><title level="j">Radiation Oncology (London, England)</title><idno type="eISSN">1748-717X</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>This study examines patient reported outcome measures of women undergoing hyperbaric oxygen treatment (HBOT) after breast-conserving therapy.</p></sec><sec><title>Method</title><p>Included were 57 women treated with HBOT for late radiation-induced tissue toxicity (LRITT) referred in the period January 2014-December 2015. HBOT consisted of (on average) 47 sessions. In total, 80 min of 100 % O<sub>2</sub> was administered under increased pressure of 2.4 ATA. Quality of life was assessed before and after treatment using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23, and a NRS pain score.</p></sec><sec><title>Results</title><p>Fifty-seven women were available for evaluation before and after treatment. Before HBOT, patients had severe complaints of pain in the arm/shoulder (46 %), swollen arm/hand (14 %), difficulty to raise arm or move it sideways (45 %), pain in the area of the affected breast (67 %), swollen area of the affected breast (45 %), oversensitivity of the affected breast (54 %), and skin problems on/in the area of the affected breast (32 %); post HBOT, severe complaints were still experienced in 17, 7, 22, 15, 13, 15, and 11 % of the women, respectively. Differences were all significant. The NRS pain score improved at least 1 point (range 0–10) in 81 % of the patients (<italic>p</italic> < 0.05).</p></sec><sec><title>Conclusion</title><p>In these breast cancer patients treated with HBOT for LRITT, the patient-reported outcomes were positive and improvements were observed. 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article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Radiat Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Radiat Oncol</journal-id><journal-title-group><journal-title>Radiation Oncology (London, England)</journal-title></journal-title-group><issn pub-type="epub">1748-717X</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27682427</article-id><article-id pub-id-type="pmc">5041335</article-id><article-id pub-id-type="publisher-id">700</article-id><article-id pub-id-type="doi">10.1186/s13014-016-0700-0</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group></article-categories><title-group><article-title>Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0002-1108-7389</contrib-id><name><surname>Teguh</surname><given-names>David N.</given-names></name><address><phone>+31-70-4063195</phone><email>d.teguh@hgcrijswijk.nl</email><email>d.n.teguh@amc.uva.nl</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Bol Raap</surname><given-names>René</given-names></name><address><email>r.bolraap@hgcrijswijk.nl</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Struikmans</surname><given-names>Henk</given-names></name><address><email>h.struikmans@mchaaglanden.nl</email></address><xref ref-type="aff" rid="Aff3">3</xref><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Verhoef</surname><given-names>Cees</given-names></name><address><email>c.verhoef@erasmusmc.nl</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Koppert</surname><given-names>Linetta B.</given-names></name><address><email>l.koppert@erasmusmc.nl</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Koole</surname><given-names>Arne</given-names></name><address><email>a.koole@hgcrijswijk.nl</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Huang</surname><given-names>Yadi</given-names></name><address><email>huangyadi@hotmail.com</email></address><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>van Hulst</surname><given-names>Rob A.</given-names></name><address><email>r.a.vanhulst@amc.uva.nl</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff6">6</xref></contrib><aff id="Aff1"><label>1</label>Hyperbaar Geneeskundig Centrum Rijswijk, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</aff><aff id="Aff2"><label>2</label>Department of Surgery/Hyperbaric Medicine, Academic Medical Center, University of Amsterdam, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</aff><aff id="Aff3"><label>3</label>Department of Radiation Oncology, Leiden University Medical Centre, Leiden, The Netherlands</aff><aff id="Aff4"><label>4</label>Radiotherapy Centre West, Medical Centre Haaglanden, The Hague, The Netherlands</aff><aff id="Aff5"><label>5</label>Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands</aff><aff id="Aff6"><label>6</label>Department of Anesthesiology/Hyperbaric Medicine, Academic Medical Center, University of Amsterdam, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</aff><aff id="Aff7"><label>7</label>University of Leuven, Treubstraat 5a, 2288 EG Rijswijk, The Netherlands</aff></contrib-group><pub-date pub-type="epub"><day>29</day><month>9</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>29</day><month>9</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>11</volume><elocation-id>130</elocation-id><history><date date-type="received"><day>14</day><month>5</month><year>2016</year></date><date date-type="accepted"><day>13</day><month>9</month><year>2016</year></date></history><permissions><copyright-statement>© The Author(s). 2016</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Introduction</title><p>This study examines patient reported outcome measures of women undergoing hyperbaric oxygen treatment (HBOT) after breast-conserving therapy.</p></sec><sec><title>Method</title><p>Included were 57 women treated with HBOT for late radiation-induced tissue toxicity (LRITT) referred in the period January 2014-December 2015. HBOT consisted of (on average) 47 sessions. In total, 80 min of 100 % O<sub>2</sub> was administered under increased pressure of 2.4 ATA. Quality of life was assessed before and after treatment using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23, and a NRS pain score.</p></sec><sec><title>Results</title><p>Fifty-seven women were available for evaluation before and after treatment. Before HBOT, patients had severe complaints of pain in the arm/shoulder (46 %), swollen arm/hand (14 %), difficulty to raise arm or move it sideways (45 %), pain in the area of the affected breast (67 %), swollen area of the affected breast (45 %), oversensitivity of the affected breast (54 %), and skin problems on/in the area of the affected breast (32 %); post HBOT, severe complaints were still experienced in 17, 7, 22, 15, 13, 15, and 11 % of the women, respectively. Differences were all significant. The NRS pain score improved at least 1 point (range 0–10) in 81 % of the patients (<italic>p</italic> < 0.05).</p></sec><sec><title>Conclusion</title><p>In these breast cancer patients treated with HBOT for LRITT, the patient-reported outcomes were positive and improvements were observed. HBOT was a well-tolerated treatment for LRITT and its side-effects were both minimal and reversible.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Breast cancer</kwd><kwd>Radiotherapy</kwd><kwd>Radiation toxicity</kwd><kwd>Fibrosis</kwd><kwd>Pain</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2016</meta-value></custom-meta></custom-meta-group></article-meta></front><body><sec id="Sec1" sec-type="introduction"><title>Introduction</title><p>In the Netherlands, around 14,000 women are diagnosed each year with invasive breast cancer; in addition about 1,900 women are diagnosed with a ductal carcinoma in situ [<ext-link ext-link-type="uri" xlink:href="http://www.oncoline.nl/">www.oncoline.nl</ext-link>]. According to the GLOBOCAN series of the International Agency for Research on Cancer, one of the most commonly diagnosed cancers worldwide is breast cancer (1.67 million) [<xref ref-type="bibr" rid="CR1">1</xref>]. Among women in the Netherlands, the cumulative lifetime breast cancer risk is 12–13 % [<ext-link ext-link-type="uri" xlink:href="http://www.oncoline.nl/">www.oncoline.nl</ext-link>]. Early detection (particularly via national breast cancer screening and improved systemic therapy) is the main factor to improve breast cancer prognosis [<ext-link ext-link-type="uri" xlink:href="http://www.oncoline.nl/">www.oncoline.nl</ext-link>]. In ≥ 60 % of patients, breast-conserving surgery is applied followed by radiotherapy. A boost dose is added in patients with a high risk of developing a true local recurrence.</p><p>When radiation is used to treat cancer it also (partly) affects a variety of critical surrounding normal tissues which can become hypocellular, hypovascular and hypoxic, frequently referred to as ‘3 H tissue’ [<xref ref-type="bibr" rid="CR2">2</xref>]. The hypoxic status of tissues can be counteracted to some extent by oxygenation of normal cells with hyperbaric oxygen therapy (HBOT). The effects of hyperbaric oxygen can be summarized as follows: short-term effects include reduction of edema and phagocytosis activation, and anti-inflammatory effects. Long-term effects include neovascularization, osteoneogenesis, and stimulation of collagen formation by fibroblasts [<xref ref-type="bibr" rid="CR3">3</xref>]. HBOT has shown beneficial effects in hypoxic diabetic ulcers that result in severe wound-healing problems and osteoradionecrosis [<xref ref-type="bibr" rid="CR4">4</xref>], and is frequently used for necrotic soft tissues and bone that fails to heal. HBOT also induces significant angiogenesis, which in one study was measurable after eight HBOT sessions [<xref ref-type="bibr" rid="CR5">5</xref>]. In addition, a significant increase in mobilization of stem cells from the bone marrow occurs when HBOT is applied [<xref ref-type="bibr" rid="CR6">6</xref>, <xref ref-type="bibr" rid="CR7">7</xref>], with wound healing and recovery of normal-tissue radiation injury as the end result [<xref ref-type="bibr" rid="CR8">8</xref>–<xref ref-type="bibr" rid="CR10">10</xref>].</p><p>In 25–33 %, breast cancer patients experiencing pain, fatigue, sexual problems, anxiety, and depression [<xref ref-type="bibr" rid="CR11">11</xref>–<xref ref-type="bibr" rid="CR13">13</xref>]. Fatigue, worsened physical functioning, disturbed body image and lower quality of life scores are the most frequently reported complaints after radiotherapy and chemotherapy [<xref ref-type="bibr" rid="CR14">14</xref>]. Late radiation-induced tissue toxicity (LRITT) has consequences for aftercare: for example, radiofibrosis influences arm movement and increases the risk of lymphedema [<xref ref-type="bibr" rid="CR15">15</xref>]. It is also reported from the EORTC 22881–10882 trial that the 10-year risk of developing moderate or severe fibrosis is 26.2 % if a radiation boost is administered (16 Gy) compared to 12.6 % in the no-boost arm [<xref ref-type="bibr" rid="CR15">15</xref>]. Other effects of LRITT include impaired cosmetic results, fibrosis of the breast, and thoracic wall pain. Fibrosis of the irradiated breast was shown to increase for up to 9 years after treatment [<xref ref-type="bibr" rid="CR16">16</xref>]. Radiation-induced thoracic wall pain occurs in 9.5–14.9 % of patients at 3-year follow-up [<xref ref-type="bibr" rid="CR17">17</xref>]. Administering a boost dose further increases the negative impact on both health-related quality of life and cosmetic outcome [<xref ref-type="bibr" rid="CR17">17</xref>]. In the Dutch Guideline for Breast Cancer (issued in 2002; revised in 2008 and 2012) HBOT is not yet mentioned due to lack of evidence regarding its efficacy in the case of LRITT [<ext-link ext-link-type="uri" xlink:href="http://www.oncoline.nl/">www.oncoline.nl</ext-link>].</p><p>More than 100 internationally recognized specialist breast cancer researchers, clinicians and healthcare professionals addressed nine thematic areas in summary papers and concluded that there is a need to incorporate standardized patient-reported outcome measures (PROMs) both in clinical trials and in everyday clinical practice [<xref ref-type="bibr" rid="CR18">18</xref>]. Deterioration in the quality of life of women treated for breast cancer has a considerable and long-term impact on their everyday functioning [<xref ref-type="bibr" rid="CR19">19</xref>]. To our knowledge no data are available regarding PROMs in patients referred for HBOT due to LRITT. Therefore, this study aimed to use PROMs before and after HBOT to examine whether HBOT can significantly reduce LRITT after breast-conserving therapy.</p></sec><sec id="Sec2" sec-type="materials|methods"><title>Methods</title><p>All patients referred to our center (January 2014 through December 2015) for HBOT due to LRITT were asked to participate in this study. Participation consisted of successively completing the following PROMs before and after HBOT: 1) the European Organization for Research and Treatment of Cancer (EORTC) core Quality of Life Questionnaire (QLQ), i.e. the QLQ-C30, 2) the disease-specific EORTC QLQ-BR23, and 3) the EQ-5D health status questionnaire and a numeric rating scale (NRS) pain score.</p><sec id="Sec3"><title>Ethics approval and consent to participate</title><p>According to the AMC Ethics Committee, no ethical approval or patient consent were needed since late radiation toxicity is a treatment indication for hyperbaric oxygen treatment and the questionnaires were distributed as part of the regular treatment evaluation.</p></sec><sec id="Sec4"><title>Hyperbaric oxygen therapy</title><p>HBOT treatment consisted of (on average) 47 sessions (1 session a day/5 days a week) in a multiplace (20-person) hyperbaric chamber. In total 80 min of 100 % oxygen was administered to patients under increased pressure of 2.4 atmospheres absolute (ATA) during a 110-min hyperbaric session. At this pressure, 100 % oxygen was delivered via an oronasal mask in four episodes of 20 min, each interrupted by 5 min of air breathing. During pressure changes, great care was taken to avoid barotraumas, particularly of the middle ear, which is the most common side-effect of a hyperbaric treatment [<xref ref-type="bibr" rid="CR20">20</xref>].</p></sec><sec id="Sec5"><title>Quality of life questionnaires</title><p>Questionnaires were given at the start of the treatment and in the last week of HBOT. The core questionnaire (QLQ-C30) applies to all patients with cancer, and the disease-specific questionnaire (QLQ-BR23) is designed specifically for patients with breast cancer. The QLQ-C30 includes 30 questions comprising both multi-item scales and single-item measures. The QLQ-BR23 comprises 23 questions incorporating items covering symptoms and side-effects related to different treatment modalities, body image, sexuality, and future perspective. For these items and scales, higher scores indicate more problems. For the QLQ-BR23, scores were dichotomized into no problems (score 1–2) and severe problems (score 3–4). In addition, a NRS (range 0–10) was used to rate pain before and after HBOT. Regarding the EQ-5D, a positive difference of at least 1 point has been noted as improvement.</p></sec><sec id="Sec6"><title>Statistical analysis</title><p>Analyses were performed in MS Excel and R (<ext-link ext-link-type="uri" xlink:href="http://www.r-project.org/">http://www.R-project.org</ext-link>)<italic>.</italic> The cumulative linked mixed model was used to compare scores before and after HBOT for the QLQ-BR23, the EQ-5D questionnaires and the NRS pain score. A two-sided p-value of 5 % was considered to be statistically significant.</p></sec></sec><sec id="Sec7" sec-type="results"><title>Results</title><p>A total of 57 female patients with pre- and post HBOT questionnaires (the QLQ-C30 and the QLQ-BR23) were available for evaluation. Table <xref rid="Tab1" ref-type="table">1</xref> presents the baseline characteristics of the study population.<table-wrap id="Tab1"><label>Table 1</label><caption><p>Characteristics of the study population (<italic>n</italic> = 57)</p></caption><table frame="hsides" rules="groups"><tbody><tr><td>Age in years: mean</td><td>59</td></tr><tr><td>Median (range)</td><td>58 (32–78)</td></tr><tr><td colspan="2">T Stage</td></tr><tr><td> Tis</td><td>2</td></tr><tr><td> T1</td><td>23</td></tr><tr><td> T2</td><td>18</td></tr><tr><td> T3</td><td>1</td></tr><tr><td> T4</td><td>1</td></tr><tr><td> Unknown</td><td>12</td></tr><tr><td colspan="2">N Stage</td></tr><tr><td> N0</td><td>29</td></tr><tr><td> N1</td><td>10</td></tr><tr><td> N2</td><td>4</td></tr><tr><td> N3</td><td>1</td></tr><tr><td> Unknown</td><td>13</td></tr><tr><td colspan="2">Time since radiotherapy (months)</td></tr><tr><td> Mean</td><td>57</td></tr><tr><td> Median (range)</td><td>33 (9–251)</td></tr><tr><td colspan="2">Maximum radiotherapy dose (Gy)</td></tr><tr><td> Mean</td><td>53</td></tr><tr><td> Median (range)</td><td>56 (19–56)</td></tr><tr><td colspan="2">Chemotherapy</td></tr><tr><td> Yes</td><td>29</td></tr><tr><td> No</td><td>27</td></tr><tr><td> Unknown</td><td>1</td></tr><tr><td colspan="2">Surgery</td></tr><tr><td> Yes</td><td>50</td></tr><tr><td> No</td><td>6</td></tr><tr><td> Unknown</td><td>1</td></tr></tbody></table></table-wrap></p><p>Before HBOT, 46, 14, 45, 67, 45, 54 and 32 % of the patients had severe complaints of pain in the arm/shoulder, swollen arm/hand, difficulty to raise the arm or to move it sideways, pain in the area of affected breast, swollen area of affected breast, oversensitivity of the affected breast, and skin problems on or in the area of the affected breast, respectively. Post HBOT, the percentages of patients with these severe complaints had decreased (Table <xref rid="Tab2" ref-type="table">2</xref>). Table <xref rid="Tab2" ref-type="table">2</xref> also shows the results of the cumulative linked mixed model analysis for the relevant questions regarding the side-effects of breast cancer irradiation. All cumulative linked mixed model coefficients were positive and significant.<table-wrap id="Tab2"><label>Table 2</label><caption><p>Scores on the EORTC BR23 Questionnaire</p></caption><table frame="hsides" rules="groups"><thead><tr><th></th><th>n</th><th>Pre HBOT, Severe problems</th><th>Post HBOT, Severe problems</th><th>Improvement</th><th>Mean Pre HBOT to Post HBOT</th><th>Cumulative linked mixed model (<italic>p</italic> value)</th></tr></thead><tbody><tr><td>Did you have any pain in your arm or shoulder?</td><td>56</td><td>46.4 %</td><td>16.7 %</td><td>42.6 %</td><td>2.4 to1.8</td><td>1.7 (<italic>p</italic> <0.05)</td></tr><tr><td>Did you have a swollen arm or hand?</td><td>56</td><td>14.3 %</td><td>7.4 %</td><td>25,9 %</td><td>1.6 to 1.4</td><td>1.2 (<italic>p</italic> <0.05)</td></tr><tr><td>Was it difficult to raise your arm or to move it sideways?</td><td>56</td><td>44.6 %</td><td>22.2 %</td><td>42.9 %</td><td>2.4 to 1.9</td><td>2.1 (<italic>p</italic> <0.05)</td></tr><tr><td>Have you had any pain in the area of your affected breast?</td><td>56</td><td>66.7 %</td><td>14.5 %</td><td>63.6 %</td><td>2.8 to 2.1</td><td>2.4 (<italic>p</italic> <0.05)</td></tr><tr><td>Was the area of your affected breast swollen?</td><td>57</td><td>44.6 %</td><td>12.7 %</td><td>57.9 %</td><td>2.4 to 1.7</td><td>2.0 (<italic>p</italic> <0.05)</td></tr><tr><td>Was the area of your affected breast oversensitive?</td><td>57</td><td>54.4 %</td><td>14.5 %</td><td>54.5 %</td><td>2.7 to 2.0</td><td>1.9 (<italic>p</italic> <0.05)</td></tr><tr><td>Have you had skin problems on or in the area of your affected breast (e.g., itchy, dry, flaky)?</td><td>57</td><td>32.1 %</td><td>11.3 %</td><td>41.5 %</td><td>2.0 to 1.6</td><td>1.5 (<italic>p</italic> <0.05)</td></tr></tbody></table></table-wrap></p><p>For the EQ-5D, 46 completed questionnaires could be analyzed. Mobility, self-care, activity, pain, and anxiety improved by 88, 50, 50, 75, and 80 %, respectively. The total EQ-5D score improved in 71 % (median 9.5 to 7.7 points) of the patients while the NRS pain score (median 5 to 2) improved in 81 % of the patients (<0.05).</p><p>The side-effects of HBOT were minimal, i.e. 8/57 patients had reversible myopia and 8/57 had reversible tiredness.</p></sec><sec id="Sec8" sec-type="discussion"><title>Discussion</title><p>This is the first study to show that breast cancer patients treated with HBOT due to LRITT significantly improved on all domains of the QLQ-BR23. In addition, the NRS score improved in the majority of these patients.</p><p>LRITT is observed in ≤ 30 % of patients treated for breast cancer [<xref ref-type="bibr" rid="CR15">15</xref>, <xref ref-type="bibr" rid="CR21">21</xref>, <xref ref-type="bibr" rid="CR22">22</xref>]. This rate is much higher than the rate of referrals for treatment of these side-effects with hyperbaric oxygen in the clinic. Serious side-effects observed after breast irradiation include impaired cosmetic results, fibrosis of the breast, and thoracic wall pain; unfortunately, for the present study population no data are available on the cosmetic results. Collette et al. published a breast fibrosis nomogram showing a strong association between radiotherapy dose and fibrosis, with large boost volumes as a prognostic factor on univariate analysis only in the EORTC 22881–10882 trials [<xref ref-type="bibr" rid="CR15">15</xref>]. Carl et al. reported on 44 patients with persisting symptoms after breast-conservation therapy: of these, 32 women received HBOT for a median of 25 sessions and 12 were control patients [<xref ref-type="bibr" rid="CR23">23</xref>]. The HBOT patients showed a significant reduction in pain, edema and erythema scores using the LENT-SOMA scale (provider reported) as compared to non-HBOT controls; in that study, fibrosis and telangiectasia were not significantly affected by HBOT [<xref ref-type="bibr" rid="CR23">23</xref>]. In their study, Mukesh et al. examined the volume effect by developing a predictive Normal Tissue Complication Probability (NTCP) model [<xref ref-type="bibr" rid="CR5">5</xref>] and suggested that the maximum radiotherapy dose is the most important parameter to influence late breast fibrosis [<xref ref-type="bibr" rid="CR24">24</xref>, <xref ref-type="bibr" rid="CR25">25</xref>]. However, the authors warned that this may reflect limitations in the current scoring system, that other radiotherapy-associated complications should also be analyzed to determine the effects of dose-volume parameters, and that PROMs should complement clinician score-based models in the future. Therefore, the authors conclude that inclusion of other clinical factors is recommended for future NTCP modeling work [<xref ref-type="bibr" rid="CR24">24</xref>, <xref ref-type="bibr" rid="CR25">25</xref>].</p><p>Vilholm et al. defined the following risk factors for the development of postmastectomy pain syndrome (PMPS): having undergone breast surgery earlier (OR 8.12), tumor located in the upper lateral quarter (OR 6.48), young age (OR 1.04), and axillary lymph node dissection (OR 1.99) [<xref ref-type="bibr" rid="CR14">14</xref>]. The authors concluded that, although advances in diagnostic and surgical procedures have reduced the frequency of the more invasive surgical procedures, there is still a considerable risk of developing PMPS after treatment for breast cancer, and that development of preventive measures (as well as treatment of the syndrome) are highly relevant [<xref ref-type="bibr" rid="CR14">14</xref>]. This might be a rationale for starting a prospective study with HBOT immediately followed by radiotherapy in a prophylactic setting.</p><p>Limitation in arm movement is another side-effect of breast cancer treatments. Kootstra et al. reported that axillary node dissection affects muscle strength, range of shoulder motion and arm volume [<xref ref-type="bibr" rid="CR26">26</xref>].</p><p>In the Cambridge Breast Intensity Modulated Radiotherapy Trial, Barnett et al. reported patient and treatment-related factors that influence late toxicity, where the greatest risk factors for the development of late toxicity 2 years after breast-conserving surgery and adjuvant breast radiotherapy are a larger breast volume independent of dose inhomogeneity, baseline pre-radiotherapy surgical cosmesis, postoperative infection, and smoking [<xref ref-type="bibr" rid="CR27">27</xref>]. Previous factors seem to be more important than dose inhomogeneity and the addition of boost radiotherapy at 2 years after the completion of radiotherapy. Unfortunately data on these factors were not available for our patients, which is a limitation of the present study. Mukesh et al. reported that skin telangiectasia is associated with older age, postoperative breast infection and tumor bed boost, and increasing breast volume [<xref ref-type="bibr" rid="CR28">28</xref>].</p><p>No prospectively randomized trials are available on the efficacy of HBOT in breast cancer patients. In a Cochrane review, Bennett et al. concluded that there is some evidence that HBOT improves outcomes in late radiation induced toxicity [<xref ref-type="bibr" rid="CR4">4</xref>]. In their large double-blind randomized study, Clarke et al. showed the substantial benefit of HBOT on quality of life in chronic refractory radiation induced proctitis [<xref ref-type="bibr" rid="CR29">29</xref>]. Glover et al. reported in a clinical trial of 46 participants in the hyperbaric oxygen group and 23 participants in the control group, no significant differences in the change of IBDQ bowel component score. From the 29 participants in the hyperbaric oxygen group and 11 participants in the sham group with rectal bleeding at baseline, also no significant differences in the change of IBDQ rectal bleeding score were seen. Several letter to the editors are published regarding the study setup thereafter in the journal [<xref ref-type="bibr" rid="CR30">30</xref>]. The possible benefit of HBOT immediately after radiotherapy to prevent/reduce late side-effects of radiation in head and neck cancer was examined in another randomized pilot study [<xref ref-type="bibr" rid="CR2">2</xref>]; this latter study showed that patients receiving hyperbaric oxygen after radiotherapy had better quality of life scores for swallowing, sticky saliva, xerostomia, and pain in the mouth. Tahir et al. presented Australia’s largest study for chronic radiation-induced tissue injuries treated with hyperbaric oxygen, evaluated by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) grading system [<xref ref-type="bibr" rid="CR20">20</xref>]. This is a provider-reported study (whereas our study reflects the patient’s point of view) in which the authors demonstrate that HBOT can be effectively applied in a variety of chronic radiation-induced tissue, including the breast.</p><p>Our HBOT protocol for LRITT of breast-conserving therapy included (on average) 47 sessions; this number was required for a maximum effect in reducing complaints. Although our protocol is usually patient-tailored for a minimum of 40 sessions, the prescribed amount of treatment varies per individual patient. Future research could examine the optimal amount of HBO treatment to reduce problems related to LRITT. The present study demonstrates a significant improvement in quality of life based on PROMs after HBOT for LRITT after breast-conserving treatment. A randomized controlled trial (including PROMs) is recommended to provide more substantial evidence concerning the value of HBOT in these patients.</p></sec><sec id="Sec9" sec-type="conclusion"><title>Conclusions</title><p>The use of PROMs in breast cancer patients treated with HBOT for radiation-induced late tissue toxicity was valuable and revealed a significant improvement in the related complaints. The side-effects of HBOT were both minimal and reversible.</p></sec></body><back><glossary><title>Abbreviations</title><def-list><def-item><term>CTCAE</term><def><p>Common Terminology Criteria for Adverse Events</p></def></def-item><def-item><term>EORTC</term><def><p>European Organization for Research and Treatment of Cancer</p></def></def-item><def-item><term>HBOT</term><def><p>Hyperbaric oxygen treatment</p></def></def-item><def-item><term>LRITT</term><def><p>Late radiation-induced tissue toxicity</p></def></def-item><def-item><term>PROMs</term><def><p>Patient-reported outcome measures</p></def></def-item><def-item><term>QLQ</term><def><p>Quality of Life Questionnaire</p></def></def-item></def-list></glossary><ack><p>The authors thank Patrick Just, Rosalinde Arnoldus, Kirsten Welbers, and Marieke Schouten for their helpful contribution to the logistics, data collection, and editing of the manuscript.</p><sec id="FPar1"><title>Funding</title><p>Not applicable.</p></sec><sec id="FPar2"><title>Availability of data and supporting materials</title><p>Data available upon request.</p></sec><sec id="FPar3"><title>Competing interests</title><p>The authors declare that they have no competing interests.</p></sec><sec id="FPar4"><title>Authors’ contributions</title><p>DT conceived in the design, coordination, statistical analysis of the study, and drafted the manuscript. RBP participated in the design and coordination of the study, and contributed to the interpretation of the data. HS contributed to the interpretation of the data, and helped to revise the manuscript. CV contributed to the interpretation of the data, and helped to revise the manuscript. LK contributed to the interpretation of the data, and helped to revise the manuscript. AK contributed to the interpretation of the data, and helped to revise the manuscript. YH performed the statistical analysis, and contributed to the interpretation of the data. RH conceived in the design, contributed to the interpretation of the data, and helped to revise the manuscript. All authors read and approved the final manuscript and declare that they have no competing interests.</p></sec><sec id="FPar5"><title>Consent for publication</title><p>Not applicable.</p></sec><sec id="FPar6"><title>Ethics approval and consent to participate</title><p>The study not needed ethical approval as the hyperbaric oxygen treatment is an treatment indication for late radiation toxicity and the questionnaires given are part of the regular treatment evaluation, no study consent was needed (AMC Ethics Committee).</p></sec></ack><ref-list id="Bib1"><title>References</title><ref id="CR1"><label>1.</label><element-citation publication-type="journal"><person-group 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