Creatine in Treating Patients With Cancer-Associated Weight Loss

Study Overview
=================
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.

Official Title
-----------------
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss

Conditions
-----------------
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes

Intervention / Treatment
-----------------
* Dietary Supplement: creatine monohydrate
* Other: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral creatine daily. | Dietary Supplement: creatine monohydrate<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo daily. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who gain weight over 1 month |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month |  | 1 month | 
| Percentage of patients who manifest stability in appetite |  | Up to 5 years | 
| Overall survival |  | Up to 5 years | 
| Incidence of treatment-related toxicity |  | Up to 5 years | 
| Quality of life |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific, cachexia, anorexia, weight changes