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NCT Number: NCT03426722

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

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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Key information

Conditions

Gastrointestinal Stromal Tumors (GISTs) Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-carnitine

Drug
  • 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

Drug

Placebo 500mg TID(PO)

Primary outcomes

  1. Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4)

    Time frame: 4 weeks

    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 outcomes

  1. Change in average numeric rating scale scores of muscle cramps

    Time frame: 4 weeks

    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

  2. Rate of patients who have duration of muscle cramps (numeric rating scale score > 4)

    Time frame: 4 weeks

    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

  3. questionnaire(Quality of Life)

    Time frame: 4 weeks

    Evaluation of the change in the Quality of Life in 4 weeks

  4. plasma concentration level

    Time frame: 1 year

    Concentration evaluation of L-carnitine

  5. recurrence rate

    Time frame: 1 year

    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)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Hanmi Pharmaceutical Company Limited

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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