Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration.

摘要: Abstract Background and purpose Tissue hardness (induration), pain tenderness are common late adverse effects of curative radiotherapy for early breast cancer. The this study was to test the efficacy IH636 grape seed proanthocyanidin extract (GSPE) in patients with tissue induration after high-dose cancer a double-blind placebo-controlled randomised phase II trial. Patients methods Sixty-six eligible research volunteers moderate or marked at mean 10.8 years since were active drug ( n =44) placebo =22). All given 100mg three times day orally, corresponding capsules, 6 months. primary endpoint percentage change surface area (cm 2 ) palpable measured skin 12 months randomisation. Secondary endpoints included photographic appearance patient self-assessment hardness, tenderness. Results At post-randomisation, ≥50% reduction recorded in13/44 (29.5%) GSPE 6/22 (27%) group (NS). there no significant difference between treatment control groups terms external assessments self-assessments Conclusions failed show orally-adminstered following