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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


Phase 2
2 Years
17 Years
Not Enrolling
Both
Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific, Weight Changes

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Trial Information

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


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 Peds-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.

Inclusion 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. 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/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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Difference between measures of weight at baseline and at week 4

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Marisa Couluris, DO

Investigator Role:

Study Chair

Investigator Affiliation:

University of South Florida

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SCUSF 0802

NCT ID:

NCT00949117

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Malnutrition
  • Myelodysplastic Syndromes
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Weight Changes
  • 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
  • Body Weight Changes
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Weight Loss
  • Lymphoma, Non-Hodgkin
  • Malnutrition
  • Lymphoma, Large-Cell, Anaplastic

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