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| Name | Class |
|---|---|
| Hanmi Pharmaceutical Company Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-carnitine | Active Comparator | L-carnitine 500mg three times daily (per oral) |
|
| Placebo | Placebo Comparator | Placebo 500mg three times daily (per oral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-carnitine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of patients who have duration of muscle cramps (numeric rating scale score > 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Koo Kang, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31628586 | Derived | 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. |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo 500mg TID(PO) |
|
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 |
| questionnaire(Quality of Life) | Evaluation of the change in the Quality of Life in 4 weeks | 4 weeks |
| plasma concentration level | Concentration evaluation of L-carnitine | 1 year |
| 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 |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |