Status:
TERMINATED
Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
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 effectiv...
Detailed Description
OBJECTIVES: Primary * To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00949117
Start Date
September 1 2009
End Date
November 1 2011
Last Update
April 2 2014
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