Status:
COMPLETED
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Hanmi Pharmaceutical Company Limited
Conditions:
Gastrointestinal Stromal Tumors (GISTs)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 qu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03426722
Start Date
March 1 2018
End Date
December 24 2019
Last Update
July 13 2020
Active Locations (1)
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1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea, 05505