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

NCT00949117 | Terminated Phase 2 Results DMC

• 3 other identifiers: SCUSF 0802SCUSF-08025U10CA081920-11
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (4)

• Body Mass Index as Assessed at Baseline and 24 Weeks

  24 weeks

• Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition

  24 weeks

• Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24

  24 weeks

• Change in Weight for Age Z-score From Baseline Through 24 Weeks

  Baseline and 24 weeks

Study Arms (2)

Arm I- cyproheptadine hydrochloride

EXPERIMENTAL

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

Drug: cyproheptadine hydrochloride

cyproheptadine HCl & PediaSure or Ensure

EXPERIMENTAL

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; Dietary Supplement: PediaSure; Drug: cyproheptadine hydrochloride

Interventions

Ensure DIETARY_SUPPLEMENT

Given orally

Also known as: nutritional supplement drink

cyproheptadine HCl & PediaSure or Ensure

PediaSure DIETARY_SUPPLEMENT

Given orally

Also known as: nutritional supplement drink (pediatric)

cyproheptadine HCl & PediaSure or Ensure

cyproheptadine hydrochloride DRUG

Given orally

Also known as: cyproheptadine HCl

Arm I- cyproheptadine hydrochloride; cyproheptadine HCl & PediaSure or Ensure

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Lymphoma; Malnutrition; Myelodysplastic Syndromes; Body Weight Changes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, Extranodal NK-T-Cell; Burkitt Lymphoma

Interventions

Cyproheptadine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Marrow Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Disease Attributes; Pathologic Processes; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Histiocytic Disorders, Malignant; Histiocytosis; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Study closed early due to slow accrual and lack of feasibility Only 1 subject completed protocol and considered in the outcome measures. Subject too young to complete PedsFAACT \& did not have prealbumin drawn at 24 week visit so outcomes not assessed

Results Point of Contact

• Title: Cristina Burroughs, Clinical Research Coordinator
• Organization: SunCoast CCOP Research Base

Cristina.Burroughs@epi.usf.edu

(813) 396-9237

Study Officials

• Marisa Couluris, DO

  University of South Florida

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 2, 2014
• Results First Posted: March 4, 2014

Record last verified: 2014-03