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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic arm | Active Comparator | In this arm, patients were given oral vitamin B prophylaxis prior to their first cycle of chemotherapy. |
|
| Non-prophylactic arm | Other | In this arm, patients were given oral vitamin B upon developing chemotherapy-induced peripheral neuropathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B Complex | Dietary Supplement | Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At baseline and up to 18 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | 11796 | Egypt |
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| Label | URL |
|---|---|
| Diabetes mellitus as a risk factor for chemotherapy-induced peripheral neuropathy: a meta-analysis | View source |
| Vitamin B6 status and chronic chemotherapy-induced peripheral neuropathy: a prospective cohort study among patients with non-metastatic colorectal cancer receiving oxaliplatin-based chemotherapy | View source |
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| 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". | 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. | up to 20 weeks. |
| Progression-free survival | 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. |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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