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.

Not Applicable

Completed

• Conditions: Peripheral Neuropathy, Chemotherapy-induced; Disease Management

• Registration Number: NCT07191587
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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.

Study Timeline

• Study Start: 2024-12-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

• Female patients with confirmed pathology of ovarian adenocarcinoma.
• Aged 18 years or older.
• Scheduled to receive a weekly paclitaxel-based chemotherapy regimen (80 mg/m²).

Exclusion Criteria

• Individuals under 18 years of age.
• Any patients with pre-existing peripheral neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)	At baseline and up to 18 weeks.	The primary outcome of this study was 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 was assessed by assessed by CTCAE v4.0 through monitoring the occurrence of peripheral neuropathy symptoms (peripheral neuropathy grade) at baseline and on weekly basis, up to 18 weeks (last follow up for chemotherapy induced peripheral neuropathy).

Secondary Outcome Measures

Name	Time	Method
Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status.	up to 20 weeks.	The CA125 status after dose modification in paclitaxel regimen due to chemotherapy-induced peripheral neuropathy or other hematological toxicities.
Number of participants with paclitaxel induced peripheral neuropathy as assessed by CTCAE v4.0 in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in neuropathy grade with vitamin B complex only.	After the first week and up to 18 weeks.
Percentage of patients that underwent dose modification in their paclitaxel regimen in both prophylactic and non-prophylactic groups due to chemotherapy-induced peripheral neuropathy as assessed by CTCAE v4.0".	After the first week and up to 18 weeks.
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade) as assessed by CTCAE v4.0 in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups.	At baseline and up to 18 weeks.
Progression-free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks.

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt