Lymphoma Clinical Trial
Official title:
An Open Label Randomized Phase II Study of an Appetite Stimulant, Cyproheptadine Hydrochloride, With and Without a Nutritional Supplement, in Children With Cancer/Treatment-Related Weight Loss
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss
caused by cancer or cancer treatment. It is not yet known whether cyproheptadine
hydrochloride is more effective with or without nutritional supplementation in improving
weight and quality of life of young patients with weight loss caused by cancer or cancer
treatment.
PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how
well it works when given together with or without nutritional supplementation in treating
young patients with weight loss caused by cancer or cancer treatment.
Status | Terminated |
Enrollment | 9 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 17 Years |
Eligibility |
INCLUSION CRITERIA: - = 2 years and < 18 years of age at the time of admission to the study - Meets one of the following criteria: - documented history of unintended weight loss > 5% presumed secondary to cancer/treatment-related therapy within three months - BMI for age less than the 5th percentile - Diagnosed with cancer of any type - Concomitant cancer treatment (surgery, chemotherapy, radiotherapy) guidelines: - Patients who will complete concomitant cancer treatment during this study's 4-week intervention are not eligible - If patients are receiving concomitant cancer treatment, they should be scheduled to get at least another 4 weeks of treatment in order to reach the primary endpoint - If patients have already completed cancer treatment, they need to be enrolled within 8 weeks of completing therapy. - Predicted life expectancy of at least 6 months EXCLUSION CRITERIA: - Currently taking any of the study agents (cyproheptadine hydrochloride (CH), PediaSure, or Ensure) or have taken any of the study agents during the past 3 weeks - History of anorexia nervosa or bulimia - Initiation of other appetite enhancing agents including steroids prescribed for the intent of weight gain, i.e. Megace, is not allowed during this study - Children receiving steroids as part of their daily cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen or in other pulse steroid therapy is allowed during the study. - Use of other forms of nutrition therapies, e.g. total parenteral nutrition (TPN) or enteral tube feedings within 3 weeks of study entry or during study - Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (SSRI), or paroxetine (SSRI) - Taking dronabinol (Marinol) or other appetite-stimulating medications during the past 3 weeks - Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease or GI or genitourinary (GU) obstruction - Allergy to study agents - Hypersensitivity to specific milk proteins - Pregnant or lactating. Females of childbearing potential are required to use effective contraception while on study agent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference Between Measures of Weight at Baseline and at Week 24 | Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period. | 24 weeks | No |
Secondary | Body Mass Index as Assessed at Baseline and 24 Weeks | Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit. | 24 weeks | No |
Secondary | Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition | 24 weeks | No | |
Secondary | Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24 | 24 weeks | No | |
Secondary | Change in Weight for Age Z-score From Baseline Through 24 Weeks | Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables. | Baseline and 24 weeks | No |
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