Creatine in Treating Patients With Cancer-Associated Weight Loss
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|ClinicalTrials.gov Identifier: NCT00081250|
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : April 29, 2020
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|
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
Experimental: Arm I
Patients receive oral creatine daily.
Dietary Supplement: creatine monohydrate
Placebo Comparator: Arm II
Patients receive oral placebo daily.
- Percentage of patients who gain weight over 1 month [ Time Frame: 1 month ]
- 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 ]
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
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|