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: Randomized phase III trial to determine the effectiveness of creatine in increasing weight and improving appetite and quality of life in patients who have weight loss caused by cancer.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific Cachexia Anorexia weight changes	Drug: creatine  Procedure: nutritional support  Procedure: supportive care/therapy	Phase III

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 274 patients (137 per arm) will be accrued for this study within approximately 19 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine ≤ 1.5 times upper limit of 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: Biologic therapy

• Not specified

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

Surgery

• Not specified

Other

• No prior creatine use
• No concurrent tube feedings or parenteral nutrition

Study chairs or principal investigators

Aminah Jatoi, MD,  Study Chair,  Mayo Clinic Cancer Center   
Charles L. Loprinzi, MD,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000360798; NCCTG-N02C4
Record last reviewed:  March 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00081250
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-09