A randomized clinical trial assessing the efficacy of vitamin B prophylaxis in attenuating paclitaxel-induced neuropathy and the imperative use of gabapentin in diabetic ovarian cancer patients

Paclitaxel being an effective treatment for ovarian cancer, presents one of the most critical toxicities; peripheral neuropathy (PN), a debilitating side effect that might limit continuation of chemotherapy. Vitamin B was found to significantly improve PN and Gabapentin is debatably used in chemotherapy induced peripheral neuropathy (CIPN). The aim of this study was to assess the efficacy of vitamin B prophylaxis in reducing the severity of CIPN, particularly in diabetic patients with the need for Gabapentin as additional therapy and the potential impact on disease response. A clinical trial of 146 adult ovarian cancer patients received Paclitaxel for 18 weeks; randomly allocated into two arms: One arm received vitamin B prophylaxis before starting Paclitaxel and other received upon CIPN. Gabapentin was given upon aggravation of CIPN. This study showed a significant reduction in CIPN grade over time, with fewer patients progressed to higher grades in prophylactic versus non-prophylactic group, extended to significant improvement in CIPN in prophylactic versus non-prophylactic diabetic patients. Gabapentin was more significantly required in non-prophylactic versus prophylactic group. A significant correlation was found between dose modification due to CIPN and CA125 status. Finally, a significant difference in PFS between prophylactic and non-prophylactic group was found at the end of the study. These results reinforce the potential role of vitamin B prophylaxis in improving patient outcomes through significantly reducing CIPN severity and minimizing the risk of dose reductions, thereby contributing to better disease response. Trial registration number: NCT07191587, date of registration: 09/24/2025, retrospectively registered.