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

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Stromal Tumors (GISTs)

Treatments: Drug: Placebo; Drug: L-carnitine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03426722

AMC1801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

L-carnitine

Active Comparator group

Description:

L-carnitine 500mg three times daily (per oral)

Treatment:

Drug: L-carnitine

Placebo

Placebo Comparator group

Description:

Placebo 500mg three times daily (per oral)

Treatment:

Drug: Placebo