Phase III Study of L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Patients With Gastrointestinal Stromal Tumors (GISTs) (Single-center Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
研究概览
简要总结
we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.
详细描述
One of the most common side effects of imatinib treatment, muscle cramps occur in about 30% of patients with gastrointestinal stromal tumor (GIST) receiving treatment with imatinib.
It affects the quality of life (QoL) of patients and could also be a factor that affects compliance with treatment. Some studies suggest that L-carnitine may improve muscle cramps associated with cirrhosis or hemodialysis. However, the efficacy of L-carnitine for muscle cramps occurring after imatinib treatment has yet to be reported. Thus, we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically confirmed GIST patients who are taking imatinib
- •Age 18years or older
- •Patients experienced muscle cramps for more than 8 times (pain of NRS > 4) or 4 times (pain of NRS >7) within last 4 weeks
- •Life expectancy > 6 months
- •ECOG performance status of 0-3
排除标准
- •Patients with renal disease receiving hemodialysis
- •Liver Cirrhosis patients with Child-Pugh class B or C
- •Patients with history of hypersensitivity to drugs including L-carnitine or nutritional supplements
- •Patients with history of spinal cord injury, peripheral vascular disease, or > Grade 2 peripheral sensory neuropathy
- •Patients with clinically significant electrolyte imbalances such as hypocalcemia, hypokalemia, and hypomagnesaemia
研究组 & 干预措施
L-carnitine
L-carnitine 500mg three times daily (per oral)
干预措施: L-carnitine (Drug)
Placebo
Placebo 500mg three times daily (per oral)
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
时间窗: 4 weeks
Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score \> 4) decreased by less than 50% in 4 weeks excluding the first 4 weeks of drug administration \*numeric rating scale scores(range, 0-10) -\> higher score is worse outcome
次要结局
- Change in average numeric rating scale scores of muscle cramps(4 weeks)
- Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)(4 weeks)
- questionnaire(Quality of Life)(4 weeks)
- plasma concentration level(1 year)
- recurrence rate(1 year)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center