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 | Completed DMC

• 1 other identifier: MO2411-505-068-193
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy, Chemotherapy-induced; Disease Management

Keywords

Vitamin B; Paclitaxel-induced peripheral neuropathy; Ovarian cancer; Diabetic; Gabapentin

Outcome Measures

Primary Outcomes (1)

• Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)

  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).

  At baseline and up to 18 weeks.

Secondary Outcomes (5)

• 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.

• 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.

• 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.

• Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status.

  up to 20 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.

Study Arms (2)

Prophylactic arm

ACTIVE COMPARATOR

In this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy.

Dietary Supplement: Vitamin B Complex

Non-prophylactic arm

OTHER

In this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy.

Dietary Supplement: Vitamin B Complex

Interventions

Vitamin B Complex DIETARY_SUPPLEMENT

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

Non-prophylactic arm; Prophylactic arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

• Diabetes mellitus as a risk factor for chemotherapy-induced peripheral neuropathy: a meta-analysis
• Vitamin B6 status and chronic chemotherapy-induced peripheral neuropathy: a prospective cohort study among patients with non-metastatic colorectal cancer receiving oxaliplatin-based chemotherapy

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Ovarian Neoplasms

Interventions

Vitamin B Complex

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 25, 2025
• Study Start: December 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)