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

Gastrointestinal Stromal Tumors (GISTs) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426722
• Other study ID #: AMC1801
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2018
• Est. completion date: December 24, 2019

Study information

• Verified date: July 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• Gastrointestinal Stromal Tumors (GISTs)
• Muscle Cramp
• Spasm

Intervention

Drug:
• L-carnitine
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.
• Placebo
Placebo 500mg TID(PO)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)	Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4) decreased by less than 50% in 4 weeks excluding the first 4 weeks of drug administration; *numeric rating scale scores(range, 0-10) -> higher score is worse outcome	4 weeks
Secondary	Change in average numeric rating scale scores of muscle cramps	Change in average numeric rating scale scores(range, 0-10) of muscle cramps in 4 weeks excluding the first 4 weeks of drug administration; *numeric rating scale scores(range, 0-10) -> higher score is worse outcome	4 weeks
Secondary	Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)	Rate of patients who have duration of muscle cramps (numeric rating scale score > 4); that was decreased by more than 50% in next 4 weeks excluding the first 4 weeks of drug administration; *numeric rating scale scores(range, 0-10) -> higher score is worse outcome	4 weeks
Secondary	questionnaire(Quality of Life)	Evaluation of the change in the Quality of Life in 4 weeks	4 weeks
Secondary	plasma concentration level	Concentration evaluation of L-carnitine	1 year
Secondary	recurrence rate	Recurrence is defined as 1) frequency of muscle cramps (NRS > 4) becomes more than 50% of baseline and 2) frequency of muscle cramps (NRS > 4) get twice worse than most improved time (when evaluated every 4 weeks)	1 year