Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer

This study has been terminated.
(study not feasible with low accrual. DSMB recommended closure)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00949117
First received: July 29, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Malnutrition
Myelodysplastic Syndromes
Unspecified Childhood Solid Tumor, Protocol Specific
Weight Changes
Dietary Supplement: Ensure
Dietary Supplement: PediaSure
Drug: cyproheptadine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Difference Between Measures of Weight at Baseline and at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Body Mass Index as Assessed at Baseline and 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.

  • Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Weight for Age Z-score From Baseline Through 24 Weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 9
Study Start Date: September 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I- cyproheptadine hydrochloride
Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Drug: cyproheptadine hydrochloride
Given orally
Other Name: cyproheptadine HCl
Experimental: cyproheptadine HCl & PediaSure or Ensure
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.
Dietary Supplement: Ensure
Given orally
Other Name: nutritional supplement drink
Dietary Supplement: PediaSure
Given orally
Other Name: nutritional supplement drink (pediatric)
Drug: cyproheptadine hydrochloride
Given orally
Other Name: cyproheptadine HCl

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

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949117

Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Marisa Couluris, DO University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00949117     History of Changes
Other Study ID Numbers: SCUSF 0802, SCUSF-0802, 5U10CA081920-11
Study First Received: July 29, 2009
Results First Received: July 8, 2013
Last Updated: March 4, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of South Florida:
malnutrition
weight changes
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia
other myeloid malignancies
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent childhood anaplastic large cell lymphoma
stage I childhood anaplastic large cell lymphoma
stage II childhood anaplastic large cell lymphoma
stage III childhood anaplastic large cell lymphoma
stage IV childhood anaplastic large cell lymphoma
recurrent childhood grade III lymphomatoid granulomatosis
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
recurrent childhood large cell lymphoma
stage I childhood large cell lymphoma
stage II childhood large cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma

Additional relevant MeSH terms:
Body Weight Changes
Leukemia
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Weight Loss
Lymphoma, Non-Hodgkin
Malnutrition
Lymphoma, Large-Cell, Anaplastic
Body Weight
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Nutrition Disorders
Lymphoma, T-Cell
Cyproheptadine
Appetite Stimulants
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014