ALC as prevention for Sagopilone-induced peripheral neuropathy v1.0
Double blind, randomized phase 2 study to evaluate the safety and efficacy of Acetyl-L-Carnitine in the prevention of Sagopilone-induced peripheral neuropathy
Bayer Schering Pharma AG
Sagopilone (a type of chemotherapy) has been shown to be effective and well tolerated for treatment of certain cancers. However, peripheral neuropathy (nerve damage of the arms and legs), has been observed in many patients treated with Sagopilone. Peripheral neuropathy symptoms include numbness and pain, but also weakness, shaking and difficulty walking, usually affecting the hands, feet, lower arms and lower legs. This can be disabling, and can have a significant impact on quality of life. Acetyl-l-carnitine (ALC) has shown activity in the treatment of peripheral neuropathy caused by chemotherapy. This study will attempt to prevent peripheral neuropathy symptoms, or at least to minimise these symptoms by adding ALC to the Sagopilone treatment. This could increase the tolerability of Sagopilone and could therefore extend the duration of treatment, which may improve the outcome of Sagopilone treatment in cancer. The effect of ALC will be studied in approximately 140 patients with ovarian or prostate cancer which has not responded to other treatments. The trial will be performed in 7European countries with 3 locations in the UK (Greater London, Leicester and Glasgow). Patients will receive a maximum of 6 treatments with Sagopilone, once every 3 weeks. Patients will also be randomly assigned to receive either ALC or placebo (â€œdummyâ€ treatment). The ALC/placebo will be given one week before, during, and 4 weeks after Sagopilone treatment. The primary objective of the trial is to demonstrate that ALC is effective (compared to placebo) in preventing Sagopilone-induced peripheral neuropathy. The safety and efficacy of this treatment regimen will also be investigated. Patients will need to visit their clinic frequently to receive Sagopilone treatment and have several tests (including blood sampling, medical check and completion of a questionnaire) performed. For the first 9 weeks, visits will mostly occur weekly, reducing to three weekly visits thereafter.
London - Central Research Ethics Committee
Date of REC Opinion
20 Oct 2008
Further Information Favourable Opinion