Creatine in Treating Patients With Cancer-Associated Weight Loss

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

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

Treatments: Dietary Supplement: creatine monohydrate; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00081250

NCCTG-N02C4

CDR0000360798 (Registry Identifier)

NCI-2012-02584 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive oral creatine daily.

Treatment:

Dietary Supplement: creatine monohydrate

Arm II

Placebo Comparator group

Description:

Patients receive oral placebo daily.

Treatment:

Other: placebo