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.
NCT ID: NCT07191587
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2024-12-01
2025-05-30
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prophylactic arm
In this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy.
Vitamin B Complex
Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.
Non-prophylactic arm
In this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy.
Vitamin B Complex
Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.
Interventions
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Vitamin B Complex
Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or older.
* Scheduled to receive a weekly paclitaxel-based chemotherapy regimen (80 mg/m²).
Exclusion Criteria
* Any patients with pre-existing peripheral neuropathy.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Locations
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National Cancer Institute
Cairo, , Egypt
Countries
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Related Links
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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
Other Identifiers
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MO2411-505-068-193
Identifier Type: -
Identifier Source: org_study_id
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