Back to resultsL-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors
Primary Purpose
Gastrointestinal Stromal Tumors (GISTs)
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
L-carnitine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors (GISTs)
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L-carnitine
Placebo
Arm Description
L-carnitine 500mg three times daily (per oral)
Placebo 500mg three times daily (per oral)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
questionnaire(Quality of Life)
Evaluation of the change in the Quality of Life in 4 weeks
plasma concentration level
Concentration evaluation of L-carnitine
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)
Full Information
NCT ID
NCT03426722
First Posted
January 29, 2018
Last Updated
July 10, 2020
Sponsor
Asan Medical Center
Collaborators
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT03426722
Brief Title
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
December 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Hanmi Pharmaceutical Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors (GISTs)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-carnitine
Arm Type
Active Comparator
Arm Description
L-carnitine 500mg three times daily (per oral)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 500mg three times daily (per oral)
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 500mg TID(PO)
Primary Outcome Measure Information:
Title
Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in average numeric rating scale scores of muscle cramps
Description
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
Time Frame
4 weeks
Title
Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)
Description
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
Time Frame
4 weeks
Title
questionnaire(Quality of Life)
Description
Evaluation of the change in the Quality of Life in 4 weeks
Time Frame
4 weeks
Title
plasma concentration level
Description
Concentration evaluation of L-carnitine
Time Frame
1 year
Title
recurrence rate
Description
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)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31628586
Citation
Chae H, Ryu MH, Ma J, Beck M, Kang YK. Impact of L-carnitine on imatinib-related muscle cramps in patients with gastrointestinal stromal tumor. Invest New Drugs. 2020 Apr;38(2):493-499. doi: 10.1007/s10637-019-00860-x. Epub 2019 Oct 18.
Results Reference
derived
Learn more about this trial
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors
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