Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.

Condition or disease	Intervention/treatment	Phase
Cancer	Drug: cyproheptadine hydrochloride; Other: placebo	Phase 3

Detailed Description:

OBJECTIVES:

Primary

• To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.

Secondary

• To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
• Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.

OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.

• Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
• Arm II: Patients receive an oral placebo twice daily for 8 weeks.

Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.

Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Supportive Care
Official Title:	Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
Study Start Date :	June 2010
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm I cyproheptadine hydrochloride; Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.	Drug: cyproheptadine hydrochloride; Given orally; Other Name: cyproheptadine HCl
Placebo Comparator: Arm II placebo; Patients receive an oral placebo twice daily for 8 weeks.	Other: placebo; Given orally

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline [ Time Frame: 8 weeks ]
2. Severity of Weight Loss [ Time Frame: Baseline and 8 weeks ]
   Change from Baseline in Weight Z score

Secondary Outcome Measures :

1. Pattern of Weight in the Study Population [ Time Frame: Baseline and 8 weeks ]
   Change from Baseline in Weight

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

• ≥ 2 years and ≤ 21 years of age at the time of study entry
• Scheduled to receive chemotherapy for:
• Newly diagnosed:
• Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
• Intermediate or high-risk neuroblastoma
• Wilms' tumor (Stage III/IV)
• Hepatoblastoma (Stage III/IV)
• Germ cell tumors (Stage III/IV)
• Brain tumors, including medulloblastoma, PNET and ependymomas
• AML
• Relapsed/recurrent disease (any patient)
• Able to register and randomize within 28 days of starting chemotherapy (registration /randomization and start of study agent may occur at anytime up to and including Day 28 after the initiation of chemotherapy)

EXCLUSION CRITERIA:

• ≥ 29 days after starting chemotherapy
• Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
• Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
• History of anorexia nervosa or bulimia
• Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
• Initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g. appetite-stimulating medications, TPN or enteral tube feedings are not allowed during this study.
• Children receiving steroids for >7 days as part of their cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen is allowed during the study
• Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil)
• Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU obstruction
• Allergy to cyproheptadine HCl
• Females of childbearing age must not be pregnant.
• Female patients who are lactating must agree to stop breast-feeding.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Miller Children's Hospital
Long Beach, California, United States, 90806
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Delaware
A.I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Hospital of Southwest Florida at Lee Memorial
Fort Myers, Florida, United States, 33908
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207-8482
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Nemours Children's Hospital Pensacola
Pensacola, Florida, United States, 32504
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States, 78207
United States, Virginia
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

University of South Florida

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Jeffrey P. Krischer, PhD	University of South Florida

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT01132547 History of Changes
Other Study ID Numbers:	SCUSF 0703; SCUSF-0703 ( Other Identifier: SunCoast CCOP Research Base ); 5U10CA081920-11 ( U.S. NIH Grant/Contract )
First Posted:	May 28, 2010
Results First Posted:	July 2, 2015
Last Update Posted:	July 2, 2015
Last Verified:	June 2015

Keywords provided by University of South Florida:

recurrent childhood subependymal giant cell astrocytoma; untreated childhood subependymal giant cell astrocytoma; cachexia; weight changes; nausea and vomiting; alveolar childhood rhabdomyosarcoma; anaplastic osteosarcoma; childhood alveolar soft-part sarcoma; childhood angiosarcoma; childhood epithelioid sarcoma; childhood fibrosarcoma; childhood gliosarcoma; childhood leiomyosarcoma; childhood liposarcoma; childhood neurofibrosarcoma

childhood synovial sarcoma; chondrosarcoma; chondrosarcomatous osteosarcoma; clear cell sarcoma of the kidney; embryonal childhood rhabdomyosarcoma; embryonal-botryoid childhood rhabdomyosarcoma; endometrial stromal sarcoma; extraosseous Ewing sarcoma; peripheral primitive neuroectodermal tumor; fibrosarcomatous osteosarcoma; localized Ewing sarcoma; localized osteosarcoma; mast cell sarcoma; metastatic childhood soft tissue sarcoma; metastatic Ewing sarcoma

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Cyproheptadine; Antipruritics; Dermatologic Agents; Gastrointestinal Agents; Histamine H1 Antagonists	Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Serotonin Antagonists; Serotonin Agents; Anti-Allergic Agents