Randomized, Placebo-Controlled Clinical Trial Combining Pentoxifylline-Tocopherol And Clodronate In The Treatment Of Radiation-Induced Plexopathy
Abstract
PURPOSE
Radiation-induced (RI) plexopathy is a rare peripheral nerve injury after radiotherapy (RT) for cancer. No treatment has been shown to slow down its progression. A pentoxifylline-vitamin E combination significantly reduced RI fibrosis and its association with clodronate (PENTOCLO) allowed healing of osteoradionecrosis and reduction of neurological symptoms in phase II trials.
METHODS
A placebo-controlled, double-blind trial conducted in adults with RI limb plexopathy without cancer recurrence, randomized in 2 arms PENTOCLO (pentoxifylline 800 mg, tocopherol 1000 mg, clodronate 1600 mg 5 days/7) or triple placebo. The primary outcome measure after 18 months of treatment was the neurological Subjective Objective Management Analytic (SOMA) score evaluating pain, paresthesia, and motor disability, RESULTS: Between 2011 and 2015, 59 patients were included: 1 false inclusion (neoplastic plexopathy), 29 treated with placebo (group P) and 29 treated with the active drugs (group A); 46 patients presented an upper limb and 12 a lower limb plexopathy. The mean delay after irradiation was 26 ±8y, patients with neurological symptoms for 5 ±5y. The median global SOMA scores, in P and A groups, respectively was 9 [6;11] vs 9 [8;11] at M0 and 9 [5;12] vs 10 [6;11] at M18 without any significant difference. Analysis of the secondary outcomes showed that SOMA score subdomains for pain and paresthesia was more affected in group A (NS). The frequency of adverse events was similar in the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 46 participants or records.
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