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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081250 |
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.
Condition | Intervention | Phase |
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Anorexia Cachexia Unspecified Adult Solid Tumor, Protocol Specific Weight Changes |
Dietary Supplement: creatine Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss |
Estimated Enrollment: | 300 |
Study Start Date: | December 2004 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral creatine daily.
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Dietary Supplement: creatine
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo daily.
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Other: placebo
Given orally
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OBJECTIVES:
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.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cancer other than primary brain cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
Study ID Numbers: | CDR0000360798, NCCTG-N02C4 |
Study First Received: | April 7, 2004 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00081250 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific cachexia anorexia weight changes |
Body Weight Signs and Symptoms Signs and Symptoms, Digestive Weight Loss Body Weight Changes |
Anorexia Creatine Cachexia Emaciation |
Body Weight Signs and Symptoms Signs and Symptoms, Digestive Weight Loss |
Body Weight Changes Anorexia Cachexia Emaciation |