Clinical trial NCT03426722: L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Stromal Tumors (GISTs)
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2018-02-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in average numeric rating scale scores of muscle cramps
timeFrame: 4 weeks
measure: Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)
timeFrame: 4 weeks
measure: questionnaire(Quality of Life)
timeFrame: 4 weeks
measure: plasma concentration level
timeFrame: 1 year
measure: recurrence rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
Study officials:
affiliation: Asan Medical Center
name: Yoon-Koo Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chae H, Ryu MH, Ma J, Beck M, Kang YK. Impact of L-carnitine on imatinib-related muscle cramps in patients with gastrointestinal stromal tumor. Invest New Drugs. 2020 Apr;38(2):493-499. doi: 10.1007/s10637-019-00860-x. Epub 2019 Oct 18.