LymphedemaV1, Main, Exploration, bibRecord, 006802

Pentoxifylline and vitamin E treatment for prevention of radiation-induced side-effects in women with breast cancer: A phase two, double-blind, placebo-controlled randomised clinical trial (Ptx-5)

Identifieur interne : 006802 ( Main/Exploration ); précédent : 006801; suivant : 006803

Pentoxifylline and vitamin E treatment for prevention of radiation-induced side-effects in women with breast cancer: A phase two, double-blind, placebo-controlled randomised clinical trial (Ptx-5)

Auteurs : Marie Magnusson [Suède] ; Peter Höglund [Suède] ; Karin Johansson [Suède] ; Charlotta Jönsson [Suède] ; Fredrika Killander [Suède] ; Per Malmström [Suède] ; Anna Weddig [Suède] ; Elisabeth Kjellen [Suède]

Source :

European journal of cancer : (1990) [ 0959-8049 ] ; 2009.

RBID : Pascal:09-0402123

Descripteurs français

Pascal (Inist)
- Pentoxifylline, Prévention, Effet secondaire, Vitamine E, Homme, Femelle, Radiothérapie, Adulte, Femme, Cancer du sein, Placebo, Essai clinique, Lymphoedème, Fibrose, Cancérologie, Traitement, Essai randomisé contrôlé, Toxine diphtérique.
Wicri :
- topic : Homme, Adulte, Femme.

English descriptors

KwdEn :
- Adult, Breast cancer, Cancerology, Clinical trial, Female, Fibrosis, Human, Lymphedema, Pentoxifylline, Pertussis toxin, Placebo, Prevention, Radiotherapy, Randomized controlled trial, Secondary effect, Treatment, Vitamin E, Woman.

Abstract

Background: A previous study has shown that pentoxifylline in combination with vitamin E can reverse radiation-induced fibrosis. The aim of the present study is to investigate if the same drugs could prevent radiation-induced side-effects in women with breast cancer. Patients and methods: A randomised, placebo-controlled, double-blind, parallel group trial was performed. Women with breast cancer were treated for 12 months with 400 mg pentoxifylline t.i.d. or placebo, in combination with 100 mg vitamin E t.i.d., starting 1-3 months after the completion of radiotherapy. The primary end-point was passive abduction of the shoulder, and the secondary end-point was difference in arm volumes. The trial is registered on the ISRCTN.org website, number ISRCTN39143623. Results: 83 patients were included in the study; 42 in the pentoxifylline + vitamin E group and 41 in the placebo + vitamin E group. Both treatments were generally well tolerated. Seven patients were withdrawn from the treatment due to disease progression; four in the pentoxifylline group and three in the placebo group. At inclusion, patients had impaired passive abduction of the shoulder. During treatment, both the groups improved significantly. Median improvement from baseline was 3.7° (p = 0.0035) on pentoxifylline and was 9.4° (p = 0.0041) in the placebo group, but no difference between the groups was detected (p = 0.20). Arm volumes increased over time in the placebo group (1.04%), but not on pentoxifylline (0.50%), and differed significantly between the groups (p = 0.0172). Conclusions: The combination of pentoxifylline and vitamin E was safe and may be used for the prevention of some radiation-induced side-effects.

Affiliations:

Suède

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Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Breast cancer</term>
<term>Cancerology</term>
<term>Clinical trial</term>
<term>Female</term>
<term>Fibrosis</term>
<term>Human</term>
<term>Lymphedema</term>
<term>Pentoxifylline</term>
<term>Pertussis toxin</term>
<term>Placebo</term>
<term>Prevention</term>
<term>Radiotherapy</term>
<term>Randomized controlled trial</term>
<term>Secondary effect</term>
<term>Treatment</term>
<term>Vitamin E</term>
<term>Woman</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Pentoxifylline</term>
<term>Prévention</term>
<term>Effet secondaire</term>
<term>Vitamine E</term>
<term>Homme</term>
<term>Femelle</term>
<term>Radiothérapie</term>
<term>Adulte</term>
<term>Femme</term>
<term>Cancer du sein</term>
<term>Placebo</term>
<term>Essai clinique</term>
<term>Lymphoedème</term>
<term>Fibrose</term>
<term>Cancérologie</term>
<term>Traitement</term>
<term>Essai randomisé contrôlé</term>
<term>Toxine diphtérique</term>
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<front><div type="abstract" xml:lang="en">Background: A previous study has shown that pentoxifylline in combination with vitamin E can reverse radiation-induced fibrosis. The aim of the present study is to investigate if the same drugs could prevent radiation-induced side-effects in women with breast cancer. Patients and methods: A randomised, placebo-controlled, double-blind, parallel group trial was performed. Women with breast cancer were treated for 12 months with 400 mg pentoxifylline t.i.d. or placebo, in combination with 100 mg vitamin E t.i.d., starting 1-3 months after the completion of radiotherapy. The primary end-point was passive abduction of the shoulder, and the secondary end-point was difference in arm volumes. The trial is registered on the ISRCTN.org website, number ISRCTN39143623. Results: 83 patients were included in the study; 42 in the pentoxifylline + vitamin E group and 41 in the placebo + vitamin E group. Both treatments were generally well tolerated. Seven patients were withdrawn from the treatment due to disease progression; four in the pentoxifylline group and three in the placebo group. At inclusion, patients had impaired passive abduction of the shoulder. During treatment, both the groups improved significantly. Median improvement from baseline was 3.7° (p = 0.0035) on pentoxifylline and was 9.4° (p = 0.0041) in the placebo group, but no difference between the groups was detected (p = 0.20). Arm volumes increased over time in the placebo group (1.04%), but not on pentoxifylline (0.50%), and differed significantly between the groups (p = 0.0172). Conclusions: The combination of pentoxifylline and vitamin E was safe and may be used for the prevention of some radiation-induced side-effects.</div>
</front>
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<affiliations><list><country><li>Suède</li>
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<tree><country name="Suède"><noRegion><name sortKey="Magnusson, Marie" sort="Magnusson, Marie" uniqKey="Magnusson M" first="Marie" last="Magnusson">Marie Magnusson</name>
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<name sortKey="Johansson, Karin" sort="Johansson, Karin" uniqKey="Johansson K" first="Karin" last="Johansson">Karin Johansson</name>
<name sortKey="Jonsson, Charlotta" sort="Jonsson, Charlotta" uniqKey="Jonsson C" first="Charlotta" last="Jönsson">Charlotta Jönsson</name>
<name sortKey="Killander, Fredrika" sort="Killander, Fredrika" uniqKey="Killander F" first="Fredrika" last="Killander">Fredrika Killander</name>
<name sortKey="Kjellen, Elisabeth" sort="Kjellen, Elisabeth" uniqKey="Kjellen E" first="Elisabeth" last="Kjellen">Elisabeth Kjellen</name>
<name sortKey="Kjellen, Elisabeth" sort="Kjellen, Elisabeth" uniqKey="Kjellen E" first="Elisabeth" last="Kjellen">Elisabeth Kjellen</name>
<name sortKey="Magnusson, Marie" sort="Magnusson, Marie" uniqKey="Magnusson M" first="Marie" last="Magnusson">Marie Magnusson</name>
<name sortKey="Malmstrom, Per" sort="Malmstrom, Per" uniqKey="Malmstrom P" first="Per" last="Malmström">Per Malmström</name>
<name sortKey="Weddig, Anna" sort="Weddig, Anna" uniqKey="Weddig A" first="Anna" last="Weddig">Anna Weddig</name>
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Pentoxifylline and vitamin E treatment for prevention of radiation-induced side-effects in women with breast cancer: A phase two, double-blind, placebo-controlled randomised clinical trial (Ptx-5)

Pentoxifylline and vitamin E treatment for prevention of radiation-induced side-effects in women with breast cancer: A phase two, double-blind, placebo-controlled randomised clinical trial (Ptx-5)

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri