The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 69
- 主要终点
- Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2
研究概览
简要总结
RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients with cancer. It is not yet known whether vitamin E is more effective than a placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works compared with placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.
详细描述
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (taxane vs cisplatin vs carboplatin vs oxaliplatin vs combination), age (≤ 50 years vs > 50 years), and gender. Patients are randomized to 1 of 2 treatment arms.
OBJECTIVES:
Primary
- Compare the incidence of chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 in patients undergoing curative neurotoxic chemotherapy for cancer treated with vitamin E vs placebo.
Secondary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Required Characteristics:
- •Scheduled to undergo curative-intent adjuvant treatment with neurotoxic chemotherapy. Patients must have had his/her tumor removed, but may have microscopic residual disease, or residual margin involvement and still be eligible.
- •The patient's chemotherapy regimen must include one or more of the following neurotoxic chemotherapeutic agents: taxanes (paclitaxel, docetaxel); platinum compounds (cisplatin, carboplatin, oxaliplatin)-(oxaliplatin patients should preferentially be enrolled in protocol N04C7 while it is available).
- •≥ 18 years of age
- •Ability to sign informed consent and understand the nature of a placebo-controlled trial
- •ECOG Performance Status (PS) of 0, 1, or 2 e.g.
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Life expectancy ≥ 6 months
- •Contraindications:
- •Undergoing chemotherapy for palliative care
- •Pre-existing history of peripheral neuropathy due to any cause (diabetes, alcohol, toxin, hereditary, etc).
- •Prior treatment with neurotoxic chemotherapy (exception: Patient started neurotoxic chemotherapy ≤ 4 days of starting vitamin E on this study and has not been treated previously with other neurotoxic chemotherapy agents).
- •Taking regular opioid-containing medications. (Exception: opioids, given for the short term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes are permitted.)
- •Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc.
- •History of coronary artery disease (i.e. MI, PTCA, or CABG ≤ 5 years or diagnosis of congestive heart failure of any NY heart class I-IV) Valve replacements are permitted as long as patient has fully recovered from the surgery.
- •Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
- •Vitamin E supplementation for any reason ≤ 7 days prior to randomization. (Exception:
- •one multivitamin per day that contains ≤ 100 IU [mg] of Vitamin E, will be permitted.)
- •Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception
- •Taking anticoagulant medication (i.e. coumadin, low molecular weight heparin (LMWH), or platelet aggregation inhibitors such as clopidgrel or aspirin) with the exception that 1 mg/day of coumadin for central line maintenance is allowed.
- •Diagnosed diabetes requiring insulin or oral hypoglycemic medications
- •Head or neck cancers
- •Scheduled to undergo radiation therapy while on study
- •History of hemorrhagic stroke
- •Patients receiving neo-adjuvant therapy
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
干预措施: placebo (Other)
Arm I
Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
干预措施: vitamin E (Dietary Supplement)
结局指标
主要结局
Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2
时间窗: 6 months post completion of chemotherapy treatment
The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.
次要结局
- Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy(6 months post completion of chemotherapy treatment)
- Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2(6 months post completion of chemotherapy treatment)
- Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy(6 months post completion of chemotherapy treatment)
- Duration of Sensory Peripheral Neuropathy ≥ Grade 2(6 months post completion of chemotherapy treatment)