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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).

Magnusson, Marie V LU ; Höglund, Peter LU ; Johansson, Karin LU ; Jönsson, Charlotta; Killander, Fredrika LU ; Malmström, Per LU ; Weddig, Anna and Kjellén, Elisabeth LU (2009) In European Journal of Cancer 45. p.2488-2495
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 12months with 400mg pentoxifylline t.i.d. or placebo, in combination with 100mg vitamin E t.i.d., starting 1-3months 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... (More)
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 12months with 400mg pentoxifylline t.i.d. or placebo, in combination with 100mg vitamin E t.i.d., starting 1-3months 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 Seven patients were withdrawn from the treatment due to disease progression; four in the pentoxifylline group and three in the placebo group.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 degrees (p=0.0035) on pentoxifylline and was 9.4 degrees (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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
European Journal of Cancer
volume
45
pages
2488 - 2495
publisher
IFAC & Elsevier Ltd.
external identifiers
  • wos:000270645100016
  • pmid:19540105
  • scopus:69249108200
ISSN
1879-0852
DOI
10.1016/j.ejca.2009.05.015
language
English
LU publication?
yes
id
a4fb1e10-3eb5-459b-ba31-71f7ca0b128d (old id 1434100)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/19540105?dopt=Abstract
date added to LUP
2009-07-03 16:24:57
date last changed
2017-09-17 05:33:34
@article{a4fb1e10-3eb5-459b-ba31-71f7ca0b128d,
  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 12months with 400mg pentoxifylline t.i.d. or placebo, in combination with 100mg vitamin E t.i.d., starting 1-3months 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 degrees (p=0.0035) on pentoxifylline and was 9.4 degrees (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.},
  author       = {Magnusson, Marie V and Höglund, Peter and Johansson, Karin and Jönsson, Charlotta and Killander, Fredrika and Malmström, Per and Weddig, Anna and Kjellén, Elisabeth},
  issn         = {1879-0852},
  language     = {eng},
  pages        = {2488--2495},
  publisher    = {IFAC & Elsevier Ltd.},
  series       = {European Journal of Cancer},
  title        = {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).},
  url          = {http://dx.doi.org/10.1016/j.ejca.2009.05.015},
  volume       = {45},
  year         = {2009},
}