Vitamin B Prophylaxis Effect on Peripheral Neuropathy Induced in Ovarian Cancer Patients Receiving Paclitaxel Based Regimen.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Individuals under 18 years of age.
- •Any patients with pre-existing peripheral neuropathy.
结局指标
主要结局
Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade)
时间窗: At baseline and up to 18 weeks.
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).
次要结局
- Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status.(up to 20 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.(After the first week 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.)
- 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.(At baseline and up to 18 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.)