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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
* L-carnitine VS Placebo is randomized (1:1) * L-carnitine 500mg TID(PO), * First evaluation will be performed at 8 weeks and then unblinding will be done. If symptoms continue after treatment, dose escalation in L-carnitine group by 1000mg TID (PO). If symptoms continue after treatment in Placebo group, L-carnitine 500mg TID(PO) will be given.
Placebo 500mg TID(PO)
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
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
Time frame: 4 weeks
Change in average numeric rating scale scores of muscle cramps
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 outcome
Time frame: 4 weeks
Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)
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 outcome
Time frame: 4 weeks
questionnaire(Quality of Life)
Evaluation of the change in the Quality of Life in 4 weeks
Time frame: 4 weeks
plasma concentration level
Concentration evaluation of L-carnitine
Time frame: 1 year
recurrence rate
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)
Time frame: 1 year
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