L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors
- Conditions
- Gastrointestinal Stromal Tumors (GISTs)
- Interventions
- Drug: Placebo
- Registration Number
- NCT03426722
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L-carnitine L-carnitine L-carnitine 500mg three times daily (per oral) Placebo Placebo Placebo 500mg three times daily (per oral)
- Primary Outcome Measures
Name Time Method Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4) 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
- Secondary Outcome Measures
Name Time Method questionnaire(Quality of Life) 4 weeks Evaluation of the change in the Quality of Life in 4 weeks
plasma concentration level 1 year Concentration evaluation of L-carnitine
Change in average numeric rating scale scores of muscle cramps 4 weeks Change in average numeric rating scale scores(range, 0-10) of muscle cramps in 4 weeks excluding the first 4 weeks of drug administration
\*numeric rating scale scores(range, 0-10) -\> higher score is worse outcomeRate of patients who have duration of muscle cramps (numeric rating scale score > 4) 4 weeks Rate of patients who have duration of muscle cramps (numeric rating scale score \> 4)
that was decreased by more than 50% in next 4 weeks excluding the first 4 weeks of drug administration
\*numeric rating scale scores(range, 0-10) -\> higher score is worse outcomerecurrence rate 1 year Recurrence is defined as 1) frequency of muscle cramps (NRS \> 4) becomes more than 50% of baseline and 2) frequency of muscle cramps (NRS \> 4) get twice worse than most improved time (when evaluated every 4 weeks)
Trial Locations
- Locations (1)
Asan Medical Center, University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of