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Gastrointestinal Stromal Tumors (GISTs)Phase 3NCT03426722

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

A Phase 3 study testing L-carnitine in people with Gastrointestinal Stromal Tumors (GISTs), run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumors (GISTs)
What is being tested?
L-carnitine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteSouth Korea
Study dates
1 Mar 2018to 24 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul, 05505

Other trials in South Korea

About this study

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)

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.

Read the 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.

Being tested
L-carnitine, Placebo
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-carnitineDrug

    • 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.

  • PlaceboDrug

    Placebo 500mg TID(PO)

Study groups in NCT03426722
Study groupRoleWhat they receive
L-carnitineActive comparatorL-carnitine 500mg three times daily (per oral)
Receives: Drug: L-carnitine
PlaceboPlacebo comparatorPlacebo 500mg three times daily (per oral)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

Secondary outcomes (5)

  1. 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

    Measured: 4 weeks

  2. 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

    Measured: 4 weeks

  3. questionnaire(Quality of Life)

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

    Measured: 4 weeks

  4. plasma concentration level

    Concentration evaluation of L-carnitine

    Measured: 1 year

  5. 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)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start1 Mar 2018
  3. Primary completion24 Dec 2019
  4. Study completion24 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426722
Sponsor's protocol ID
AMC1801
Status last verified
Jul 2020
First submitted
29 Jan 2018
Last updated
13 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31628586

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing L-carnitine in people with Gastrointestinal Stromal Tumors (GISTs), run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.

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