A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of Vincristine-induced Peripheral Neuropathy
研究概览
简要总结
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.
PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the incidence of vincristine-induced peripheral neuropathy in pediatric patients with lymphoma, leukemia, or solid tumors.
Secondary
- Compare the safety of glutamine vs placebo in these patients.
- Compare the efficacy of glutamine vs placebo in reducing the progression and/or resolution of vincristine-induced peripheral neuropathy in these patients.
- Compare the effect of glutamine supplementation vs placebo on chemotherapy-related toxicities in these patients.
- Compare the effect of glutamine vs placebo on measures of quality of life in these patients.
- Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor and glutamine levels in these patients.
- Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.
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
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 5 and 21 years old.
- •Patients who demonstrate the ability to complete the assessment instruments at baseline.
- •Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.
排除标准
- •Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
- •Patients with recurrent disease.
- •Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
- •Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
- •Patients with hepatic encephalopathy or hyperammonemia.
- •Patients with a focally abnormal neurologic exam.
研究组 & 干预措施
Arm I: Glutamine
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
干预措施: Glutamine (Drug)
Arm II: Placebo
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Vincristine-induced Peripheral Neuropathy
时间窗: Up to 30 weeks from baseline while on Vincristine treatment
次要结局
- Number of Participants With Progression of Neuropathy(42 days)
研究者
Julia Glade Bender
Irving Assistant Professor of Clinical Pediatrics
Columbia University