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

Phase 3
18 Years
Open (Enrolling)
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months


- Not specified


- Not specified


- Creatinine normal


- No poorly controlled congestive heart failure

- No poorly controlled hypertension


- 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


Biologic therapy

- Not specified


- 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


- No concurrent radiotherapy to the bowel or stomach

- Other concurrent radiotherapy allowed


- Not specified


- No prior creatine use

- No concurrent tube feedings or parenteral nutrition

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Percentage of patients who gain weight over 1 month

Safety Issue:


Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Weight Changes
  • unspecified adult solid tumor, protocol specific
  • cachexia
  • anorexia
  • weight changes
  • Anorexia
  • Body Weight Changes
  • Cachexia
  • Weight Loss



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