Clinical trial · Interventional
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)
NCT03426722CI-TRIAL-00045922completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors (GISTs) | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L-carnitine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- L-carnitine
- description
- L-carnitine 500mg three times daily (per oral)
- interventionNames
- Drug: L-carnitine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo 500mg three times daily (per oral)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChae 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. PMID 31628586