NCT07191587

A Controlled 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 and the Potential Effect on Disease Response.

Vitamin B Prophylaxis Effect on Peripheral Neuropathy Induced in Ovarian Cancer Patients Receiving Paclitaxel Based Regimen.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if vitamin B prophylaxis is effective in attenuating chemotherapy-induced peripheral neuropathy in adult ovarian cancer patients. The main questions (primary outcomes) it aims to answer are: * The severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group. * Severity of chemotherapy-induced peripheral neuropathy in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups. Participants will: Take drug oral vitamin B complex every day as prophylaxis for 6 months. Visit the clinic once every week for their weekly Paclitaxel regimen, checkups and tests. Keep a diary of their symptoms.

Detailed description

Patients received oral vitamin B complex as prophylaxis prior to starting their paclitaxel-based regimen and patients in the non-prophylaxis group received oral vitamin B complex upon developing chemotherapy-induced peripheral neuropathy during their treatment with paclitaxel-base regimen. Gabapentin was given to the patients in either groups upon aggravation of CIPN symptoms whether in severity or neuropathic pain according to peripheral neuropathy grading. Secondary outcomes: * The number of patients in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in CIPN with vitamin B complex only. * Impact of vitamin B complex prophylaxis on dose modification of paclitaxel-based regimen. * Association between dose modification and CA 125 status. * Progression-free survival (PFS) was evaluated at the end of the study.

Conditions

• Peripheral Neuropathy, Chemotherapy-induced
• Disease Management

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin B Complex	Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-04-30
• Completion: 2025-05-30
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: Egypt