NCT03426722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2019

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

January 29, 2018

Last Update Submit

July 10, 2020

Conditions

Gastrointestinal Stromal Tumors (GISTs)

Outcome Measures

Primary Outcomes (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

    4 weeks

Secondary Outcomes (5)

  • Change in average numeric rating scale scores of muscle cramps

    4 weeks

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

    4 weeks

  • questionnaire(Quality of Life)

    4 weeks

  • plasma concentration level

    1 year

  • recurrence rate

    1 year

Study Arms (2)

L-carnitine

ACTIVE COMPARATOR

L-carnitine 500mg three times daily (per oral)

Drug: L-carnitine

Placebo

PLACEBO COMPARATOR

Placebo 500mg three times daily (per oral)

Drug: Placebo

Interventions

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.

L-carnitine
PlaceboDRUG

Placebo 500mg TID(PO)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31628586DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Yoon-Koo Kang, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 8, 2018

Study Start

March 1, 2018

Primary Completion

December 24, 2019

Study Completion

December 24, 2019

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

KR(1)