Overview

L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors

Status:
Completed

Trial end date:
2019-12-24

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Asan Medical Center

Collaborator:

Hanmi Pharmaceutical Company Limited

Treatments:

Imatinib Mesylate

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