MedTrace Logo

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.

NCT07191587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Peripheral Neuropathy, Chemotherapy-induced
  • Disease Management

Interventions

DIETARY_SUPPLEMENT

Vitamin B Complex

Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-04-30
Completion
2025-05-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191587 on ClinicalTrials.gov