Clinical trial · Interventional
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.
Vitamin B Prophylaxis Effect on Peripheral Neuropathy Induced in Ovarian Cancer Patients Receiving Paclitaxel Based Regimen.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease Management | — | UNRESOLVED | — |
| Peripheral Neuropathy, Chemotherapy-induced | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin B Complex | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prophylactic arm
- description
- In this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy.
- interventionNames
- Dietary Supplement: Vitamin B Complex
- type
- OTHER
- label
- Non-prophylactic arm
- description
- In this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy.
- interventionNames
- Dietary Supplement: Vitamin B Complex
Primary outcomes (1)
- measure
- Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available