Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Creatine in Treating Patients With Cancer-Associated Weight Loss

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over NCI NCCTG-N02C4 NCT00081250, N02C4

Objectives

1. Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia.
2. Determine the effect of these regimens on quality of life in these patients.
3. Compare the toxic effects of these regimens in these patients.
4. Compare survival rates of patients treated with these regimens.

Entry 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

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

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 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

Expected Enrollment

A total of 300 patients will be accrued for this study.

Outcomes

Percentage of patients who gain weight over 1 month

Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month
Percentage of patients who manifest stability in appetite
Overall survival
Incidence of treatment-related toxicity
Quality of life

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-2511
Charles Loprinzi, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Trial Start Date		2004-12-17
Registered in ClinicalTrials.gov		NCT00081250
Date Submitted to PDQ		2005-05-02
Information Last Verified		2007-11-09

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