Gastrointestinal Stromal Tumors (GISTs)
Conditions
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.
Interventions
DRUGL-carnitine
* 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.
DRUGPlacebo
Placebo 500mg TID(PO)
Sponsors
Hanmi Pharmaceutical Company Limited
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed GIST patients who are taking imatinib 2. Age 18years or older 3. Patients experienced muscle cramps for more than 8 times (pain of NRS \> 4) or 4 times (pain of NRS \>7) within last 4 weeks 4. Life expectancy \> 6 months 5. ECOG performance status of 0-3
Exclusion criteria
1. Patients with renal disease receiving hemodialysis 2. Liver Cirrhosis patients with Child-Pugh class B or C 3. Patients with history of hypersensitivity to drugs including L-carnitine or nutritional supplements 4. Patients with history of spinal cord injury, peripheral vascular disease, or \> Grade 2 peripheral sensory neuropathy 5. Patients with clinically significant electrolyte imbalances such as hypocalcemia, hypokalemia, and hypomagnesaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 outcome |
| Rate 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 outcome |
| 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 |
| recurrence 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) |
Countries
South Korea
Outcome results
None listed