Overview

This trial is active, not recruiting.

Conditions anorexia, cachexia, unspecified adult solid tumor, protocol specific, weight changes
Treatments creatine monohydrate, placebo
Phase phase 3
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date December 2004
End date December 2007
Trial size 300 participants
Trial identifier NCT00081250, CDR0000360798, NCCTG-N02C4, NCI-2012-02584

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Patients receive oral creatine daily.
creatine monohydrate
Given orally
(Placebo Comparator)
Patients receive oral placebo daily.
placebo
Given orally

Primary Outcomes

Measure
Percentage of patients who gain weight over 1 month
time frame: 1 month

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.