Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of neuropathy in patients receiving paclitaxel

Trials

Study Protocol

Prabhat Singh Malik¹  Sachin Khurana¹  Deepam Pushpam¹  Ajay Gogia¹  Praful Pandey¹  Akash Kumar¹  Atul Batra¹  Mamta Bhushan Singh²  Elavarasi Arunmozhimaran²  Dinu Santha Chandran³ 

[1] Department of Medical Oncology, Dr. BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, 110029, New Delhi, India;Department of Neurology, All India Institute of Medical Science, New Delhi, India;Department of Physiology, All India Institute of Medical Science, New Delhi, India;

关键词: Paclitaxel;    Neuropathy;    Gabapentin;    Breast cancer;    Ovarian cancer;    Prevention;   

DOI  :  10.1186/s13063-023-07126-1

 received in 2022-08-05, accepted in 2023-01-30,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPeripheral neuropathy is a common dose-limiting side effect of paclitaxel. To date, there is no effective strategy to prevent paclitaxel-induced peripheral neuropathy. A recent small phase II study demonstrated the potential role of oral gabapentin in this setting. This phase III study is aimed to assess the efficacy of oral gabapentin in preventing paclitaxel-induced neuropathy.ObjectiveTo compare the efficacy of oral gabapentin with placebo in preventing clinically significant peripheral neuropathy (NCI CTCAEv5.0 grade 2 or higher) in patients receiving paclitaxel.MethodsThis is a randomized, placebo-controlled, double-blind, parallel-group superiority trial. The primary outcome is the development of grade 2 or higher chemotherapy-induced peripheral neuropathy. Secondary outcomes include any grade neuropathy, the percentage change in sensory nerve conduction velocities in peripheral nerves, time to development of any grade neuropathy, paclitaxel dose reductions and delays due to peripheral neuropathy, patient-reported outcomes, adverse events, and adherence to oral therapy. A total of 136 patients receiving paclitaxel will be randomly allocated (stratified by weekly vs. non-weekly administration) to receive either oral gabapentin or placebo till three weeks after the last dose of chemotherapy or occurrence of the primary outcome.ConclusionThis study aims to find if oral gabapentin reduces the incidence of grade 2 or higher chemotherapy-induced peripheral neuropathy in patients receiving paclitaxel.Trial registrationThe trial is registered prospectively with the Clinical Trials Registry of India (CTRI/2022/02/040030) on April 4, 2022.

【 授权许可】

CC BY   
© The Author(s) 2023