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Creatine in Treating Patients With Cancer-Associated Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081250
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE April 7, 2004
First Posted Date  ICMJE April 8, 2004
Last Update Posted Date August 8, 2017
Actual Study Start Date  ICMJE December 2004
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Percentage of patients who gain weight over 1 month [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month [ Time Frame: 1 month ]
  • Percentage of patients who manifest stability in appetite [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • Incidence of treatment-related toxicity [ Time Frame: Up to 5 years ]
  • Quality of life [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creatine in Treating Patients With Cancer-Associated Weight Loss
Official Title  ICMJE Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Brief Summary

RATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer.

PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.

Detailed Description

OBJECTIVES:

  • Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia.
  • Determine the effect of these regimens on quality of life in these patients.
  • Compare the toxic effects of these regimens in these patients.
  • Compare survival rates of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss severity (< 10 lbs vs ≥10 lbs), age (< 50 years vs ≥ 50 years), planned concurrent chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral creatine daily.
  • Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the absence of unacceptable toxicity as long as treatment is considered beneficial.

Patients are followed every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anorexia
  • Cachexia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Weight Changes
Intervention  ICMJE
  • Dietary Supplement: creatine monohydrate
    Given orally
  • Other: placebo
    Given orally
Study Arms  ICMJE
  • Experimental: Arm I
    Patients receive oral creatine daily.
    Intervention: Dietary Supplement: creatine monohydrate
  • Placebo Comparator: Arm II
    Patients receive oral placebo daily.
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 20, 2007)
300
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cancer other than primary brain cancer

    • Considered incurable with available therapies
  • History of weight loss ≥ 5 lbs in 2 months or fewer AND/OR estimated intake of < 20 cal/kg daily
  • Determination by attending physician that weight gain would benefit patient
  • Perception by patient that weight loss is a problem
  • No symptomatic or untreated brain metastases
  • No clinical evidence of ascites

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Renal

  • Creatinine normal

Cardiovascular

  • No poorly controlled congestive heart failure
  • No poorly controlled hypertension

Other

  • Able to reliably receive oral medication
  • Must be alert and mentally competent
  • No known obstruction of the alimentary tract, malabsorption, or intractable vomiting
  • No diabetes that is controlled by insulin
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • Concurrent chemotherapy allowed

Endocrine therapy

  • No other concurrent adrenal corticosteroids, androgens, or progestational agents within 30 days after study entry
  • Concurrent short-term dexamethasone for chemotherapy-associated emesis is allowed
  • Concurrent inhalant, topical, or optical steroids allowed

Radiotherapy

  • No concurrent radiotherapy to the bowel or stomach
  • Other concurrent radiotherapy allowed

Other

  • No prior creatine use
  • No concurrent tube feedings or parenteral nutrition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00081250
Other Study ID Numbers  ICMJE NCCTG-N02C4
NCI-2012-02584 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000360798 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Aminah Jatoi, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP