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NCT Number: 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.

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.

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Key information

Conditions

Peripheral Neuropathy, Chemotherapy-induced Adnexal Diseases Disease Management Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Ovarian Diseases Ovarian Neoplasms Peripheral Nervous System Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, 11796, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin B Complex

Dietary Supplement

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

Primary outcomes

  1. Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)

    Time frame: 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 outcomes

  1. 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.

    Time frame: After the first week and up to 18 weeks.

  2. 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.

    Time frame: At baseline and up to 18 weeks.

  3. 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".

    Time frame: After the first week and up to 18 weeks.

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

    Time frame: up to 20 weeks.

    The CA125 status after dose modification in paclitaxel regimen due to chemotherapy-induced peripheral neuropathy or other hematological toxicities.

  5. Progression-free survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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