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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

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.


Condition or disease Intervention/treatment Phase
Anorexia Cachexia Unspecified Adult Solid Tumor, Protocol Specific Weight Changes Dietary Supplement: creatine monohydrate Other: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Actual Study Start Date : December 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I
Patients receive oral creatine daily.
Dietary Supplement: creatine monohydrate
Given orally

Placebo Comparator: Arm II
Patients receive oral placebo daily.
Other: placebo
Given orally




Primary Outcome Measures :
  1. Percentage of patients who gain weight over 1 month [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month [ Time Frame: 1 month ]
  2. Percentage of patients who manifest stability in appetite [ Time Frame: Up to 5 years ]
  3. Overall survival [ Time Frame: Up to 5 years ]
  4. Incidence of treatment-related toxicity [ Time Frame: Up to 5 years ]
  5. Quality of life [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081250


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Aminah Jatoi, MD Mayo Clinic

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00081250    
Other Study ID Numbers: NCCTG-N02C4
NCI-2012-02584 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000360798 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Keywords provided by Alliance for Clinical Trials in Oncology:
unspecified adult solid tumor, protocol specific
cachexia
anorexia
weight changes
Additional relevant MeSH terms:
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Wasting Syndrome
Body Weight
Weight Loss
Anorexia
Cachexia
Body Weight Changes
Signs and Symptoms
Signs and Symptoms, Digestive
Emaciation
Metabolic Diseases
Nutrition Disorders