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

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)

Sponsors

Lead Sponsor: Asan Medical Center

Collaborator: Hanmi Pharmaceutical Company Limited

Source Asan Medical Center
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.

Overall Status Completed
Start Date March 1, 2018
Completion Date December 24, 2019
Primary Completion Date December 24, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4) 4 weeks
Secondary Outcome
Measure Time Frame
Change in average numeric rating scale scores of muscle cramps 4 weeks
Rate of patients who have duration of muscle cramps (numeric rating scale score > 4) 4 weeks
questionnaire(Quality of Life) 4 weeks
plasma concentration level 1 year
recurrence rate 1 year
Enrollment 4
Condition
Intervention

Intervention Type: Drug

Intervention Name: L-carnitine

Description: 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.

Arm Group Label: L-carnitine

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo 500mg TID(PO)

Arm Group Label: Placebo

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Yoon-Koo Kang, MD, PhD Principal Investigator Asan Medical Center
Location
Facility: Asan Medical Center, University of Ulsan College of Medicine
Location Countries

Korea, Republic of

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Asan Medical Center

Investigator Full Name: Yoon-Koo Kang

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: L-carnitine

Type: Active Comparator

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

Label: Placebo

Type: Placebo Comparator

Description: Placebo 500mg three times daily (per oral)

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov