Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
Information source: University of South Florida
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Malnutrition; Myelodysplastic Syndromes; Unspecified Childhood Solid Tumor, Protocol Specific; Weight Changes
Intervention: Ensure (Dietary Supplement); PediaSure (Dietary Supplement); cyproheptadine hydrochloride (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: University of South Florida Official(s) and/or principal investigator(s): Marisa Couluris, DO, Study Chair, Affiliation: University of South Florida
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 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Difference Between Measures of Weight at Baseline and at Week 24
Secondary outcome: Body Mass Index as Assessed at Baseline and 24 WeeksEffect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24 Change in Weight for Age Z-score From Baseline Through 24 Weeks
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 the duration of response in pediatric patients with cancer- or cancer
treatment-related weight loss.
Secondary
- To compare patterns of body composition and weight change in patients treated with
these regimens.
- To compare the change in the relationship between pre-albumin (biomarker of
malnutrition) and weight improvement from baseline to the completion of study
treatment.
- To compare the change in quality of life as measured by the Pediatric Functional
Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated
with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24
weeks in the absence of weight loss or unacceptable toxicity.
- Arm II: Patients receive oral cyproheptadine hydrochloride twice daily and oral
PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24
weeks in the absence of weight loss or unacceptable toxicity.
Patients undergo blood sample collection to assess pre-albumin levels at baseline and at
weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and
percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height
at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice
a week during study treatment.
Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks
4 and 24.
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: September 2009
Last updated: March 4, 2014
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