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Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer - NCT01132547-33612(Clinical Trial 651595)



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City:  Tampa
State:  
FL
Zip Code: 33612
Conditions: Cachexia - Nausea and Vomiting - Unspecified Childhood Solid Tumor, Protocol Specific - Body Weight Changes
Purpose: RATIONALE: Cyproheptadine may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer. PURPOSE: This randomized phase III trial is studying cyproheptadine to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
Study summary: OBJECTIVES: Primary - To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy. Secondary - To assess the pattern of weight change between two groups (treatment vs placebo) during the study. - To investigate the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition between two groups at completion of therapy compared to baseline measures. - To investigate the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition within the treatment group at completion of therapy compared to baseline measures, specifically those patients with no weight loss as compared to those patients who experience weight loss. OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and steroid use with cancer treatment (yes vs no). Patients begin study treatment before the first dose of chemotherapy. - Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 16 weeks. - Arm II: Patients receive an oral placebo twice daily for 16 weeks. Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4, 8, 12, and 16 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4, 8, 12, and 16 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study. Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin and transferrin levels.
Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed cancer - No diagnosis of acute lymphocytic leukemia - Scheduled to receive moderately or highly emetic chemotherapy as outlined in the 2006 ASCO Recommendations - Patients on multi-drug regimens, with varying emetic potential, are classified according to the agent with the highest emetic potential - No documented unintended weight loss of > 5% presumed secondary to cancer within the past 3 months PATIENT CHARACTERISTICS: - Not pregnant or nursing - Fertile patients must use effective contraception - No history of anorexia nervosa or bulimia - No BMI ≥ the 95th percentile at registration - No allergy to cyproheptadine hydrochloride - No diagnoses of glaucoma or gastrointestinal/genitourinary obstruction PRIOR CONCURRENT THERAPY: - More than 3 weeks since prior and no concurrent cyproheptadine hydrochloride - No concurrent monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (SSRI), or paroxetine (SSRI) - More than 3 weeks since prior appetite-stimulating medications (i.e., dronabinol) - No initiation of other appetite-enhancing agents (i.e., steroids prescribed for the intent of weight gain) during the study - Steroid use scheduled as part of chemotherapy regimen is allowed - No initiation of other forms of nutrition (e.g., total parenteral nutrition or enteral tube feedings)
Study is available at: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, FL 33612
United States

Primary Contact:
Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese
Email: canceranswers@moffitt.org
Phone: 800-456-7121
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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