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

Primary Purpose

Leukemia, Lymphoma, Malnutrition

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ensure
PediaSure
cyproheptadine hydrochloride
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring 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, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, childhood nasal type extranodal NK/T-cell lymphoma, childhood Burkitt lymphoma, recurrent childhood small noncleaved cell lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, childhood myelodysplastic syndromes, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, unspecified childhood solid tumor, protocol specific

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm I- cyproheptadine hydrochloride

    cyproheptadine HCl & PediaSure or Ensure

    Arm Description

    Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Effect 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
    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.

    Full Information

    First Posted
    July 29, 2009
    Last Updated
    March 4, 2014
    Sponsor
    University of South Florida
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00949117
    Brief Title
    Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    study not feasible with low accrual. DSMB recommended closure
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of South Florida
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific, Weight Changes
    Keywords
    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, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, childhood nasal type extranodal NK/T-cell lymphoma, childhood Burkitt lymphoma, recurrent childhood small noncleaved cell lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, childhood myelodysplastic syndromes, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, unspecified childhood solid tumor, protocol specific

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I- cyproheptadine hydrochloride
    Arm Type
    Experimental
    Arm Description
    Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
    Arm Title
    cyproheptadine HCl & PediaSure or Ensure
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ensure
    Other Intervention Name(s)
    nutritional supplement drink
    Intervention Description
    Given orally
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PediaSure
    Other Intervention Name(s)
    nutritional supplement drink (pediatric)
    Intervention Description
    Given orally
    Intervention Type
    Drug
    Intervention Name(s)
    cyproheptadine hydrochloride
    Other Intervention Name(s)
    cyproheptadine HCl
    Intervention Description
    Given orally
    Primary Outcome Measure Information:
    Title
    Difference Between Measures of Weight at Baseline and at Week 24
    Description
    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.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Body Mass Index as Assessed at Baseline and 24 Weeks
    Description
    Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.
    Time Frame
    24 weeks
    Title
    Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition
    Time Frame
    24 weeks
    Title
    Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24
    Time Frame
    24 weeks
    Title
    Change in Weight for Age Z-score From Baseline Through 24 Weeks
    Description
    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.
    Time Frame
    Baseline and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marisa Couluris, DO
    Organizational Affiliation
    University of South Florida
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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