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 M et al. - In a trial to investigate if the same drugs could prevent radiation-induced side-effects in women with breast cancer, it was concluded that the combination of pentoxifylline and vitamin E was safe and may be used for prevention of some radiation-induced side-effects. Methods- Women with breast cancer were treated for 12 mos with 400 mg pentoxifylline tid or placebo, in combination with 100 mg vitamin E tid, starting 1–3 mos after the completion of radiotherapy.
- Primary end-point was passive abduction of the shoulder, and the secondary endpoint was difference in arm volumes.
Results- 83 pts 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.
- 7 pts were withdrawn from the treatment due to disease progression; 4 in the pentoxifylline group and 3 in the placebo group.
- At inclusion, pts had impaired passive abduction of the shoulder.
- During treatment, both the groups improved significantly.
- Median improvement from baseline was 3.7° on pentoxifylline and was 9.4° in the placebo group, but no difference between the groups was detected.
- Arm volumes increased over time in the placebo group (1.04%), but not on pentoxifylline (0.50%), and differed significantly between the groups.
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