Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
creatine monohydrate
+ placebo
Anorexia+7
+ Body Weight
+ Body Weight Changes
Supportive Care Study
Summary
Study start date: December 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 217 locations
Mayo Clinic Scottsdale
Scottsdale, United StatesAurora Presbyterian Hospital
Aurora, United StatesBoulder Community Hospital
Boulder, United States