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.

National Cancer Institute, Egypt

Status: Completed

Conditions: Peripheral Neuropathy, Chemotherapy-induced; Disease Management

Treatments: Dietary Supplement: Vitamin B Complex

Study type: Interventional

Funder types: Other

Identifiers

NCT07191587

MO2411-505-068-193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Prophylactic arm

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin B Complex

Non-prophylactic arm

Other group

Description:

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

Treatment:

Dietary Supplement: Vitamin B Complex