An interventional study of Vitamin B Complex in Peripheral Neuropathy, Chemotherapy-induced and Disease Management, sponsored by National Cancer Institute, Egypt. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Prevention
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:
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.
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:
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 146 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy.
Dietary Supplement: Vitamin B Complex
In this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy.
Dietary Supplement: Vitamin B Complex
Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.
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).
Time frame: At baseline and up to 18 weeks.
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.
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.
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.
Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status.
The CA125 status after dose modification in paclitaxel regimen due to chemotherapy-induced peripheral neuropathy or other hematological toxicities.
Time frame: up to 20 weeks.
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.
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
National Cancer Institute, Egypt