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Phase III Randomized Study of Creatine in Patients With Cancer-Associated Weight Loss
Alternate Title Basic Trial Information Objectives Entry Criteria Projected Accrual Outline Trial Contact Information
Alternate Title
Creatine in Treating Patients With Cancer-Associated Weight Loss
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Supportive care
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Approved-not yet active
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18 and over
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NCI
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NCCTG-N02C4
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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.
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 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 Other - No prior creatine use
- No concurrent tube feedings or parenteral nutrition
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic 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
Projected Accrual A total of 274 patients (137 per arm) will be accrued for this study within approximately 19 months. 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. Disclaimer The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group | | | Aminah Jatoi, MD, Protocol chair | | | | Charles Loprinzi, MD, Protocol co-chair | | | | Back to Top |
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