Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Basic Trial Information

Objectives

Primary

1. 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

1. 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.
2. To 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.

Entry Criteria

Disease Characteristics:

• Scheduled to receive chemotherapy for:
  • Newly diagnosed disease:
    • Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma, and any stage Ewing 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, primitive neuroectodermal tumors (PNET), and ependymomas
    • Acute myelogenous leukemia (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)

• No documented unintended weight loss of > 5% presumed secondary to cancer within the past 3 months

Prior/Concurrent Therapy:

• More than 3 weeks since prior and no other concurrent cyproheptadine hydrochloride
• No concurrent monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (selective serotonin reuptake inhibitor [SSRI]), or paroxetine (SSRI)
• More than 3 weeks since prior appetite-stimulating medications (i.e., dronabinol)
• No initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace
  • 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
  • Children receiving steroids for ≤ 7 days may be included
  • Intermittent steroid use in an antiemetic regimen is allowed during the study

Patient Characteristics:

• Females of childbearing age must not be pregnant
• Female patients who are lactating must agree to stop breast-feeding
• No history of anorexia nervosa or bulimia
• No allergy to cyproheptadine hydrochloride
• No diagnoses of glaucoma or gastrointestinal/genitourinary obstruction

Expected Enrollment

Outcomes

Efficacy of cyproheptadine HCl in the prevention of cancer/treatment-related weight loss, defined as weight loss ≥ 5% at the 4 or 8- week assessment when compared to baseline

The effect of cyproheptadine HCL on weight for age Z scores
Duration of response
The difference of pre-albumin, triceps skin fold, mid-arm circumference, and weight loss between end of the study and baseline measurement within each of the treatment groups (treatment and placebo) separately

Outline

This is a multicenter study. Patients are stratified according to treatment 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 and transferrin levels.

Trial Contact Information

Trial Lead Organizations

SunCoast CCOP Research Base at the University of South Florida

Jeffrey Krischer, MD, PhD, Principal investigator		Ph: 813-979-6706; 800-909-1242

U.S.A.
California
	Los Angeles
	Kaiser Permanente Medical Center - Los Angeles
		Robert Cooper, MD, CCRP	Ph:  323-783-8831
			Email: olga.e.osuna@kp.org
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Gregory Griffin, MD	Ph:  302-651-5528
			Email: pcawood@nemours.org
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Hector Rodriguez-Cortes, MD	Ph:  954-355-5488
			Email: cdiazpowsang@browardhealth.org
	Fort Myers
	Children's Hospital of Southwest Florida
		Emad Salman, MD	Ph:  239-343-6959
			Email: carolyn.bell@leememorial.org
	Jacksonville
	Nemours Children's Clinic
		Eric Sandler, MD	Ph:  904-697-3817
			Email: mbarry@nemours.org
	Orlando
	Arnold Palmer Hospital for Children
		Don Eslin, MD	Ph:  321-841-3837
			Email: stephanie.garber@orlandohealth.com
	Nemours Children's Clinic - Orlando
		Paul Gordon, MD	Ph:  407-650-7652
			Email: krwilson@nemours.org
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org
Hawaii
	Honolulu
	Kapiolani Medical Center for Women and Children
		Robert Wilkinson, MD	Ph:  808-586-2979
			Email: emelie@crch.hawaii.edu
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Gail Megason, MD	Ph:  601-984-5224
			Email: rlowery@umc.edu
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein, MD	Ph:  702-496-2857
			Email: s.yule@sncrf.org
	Sunrise Hospital and Medical Center
		Jonathan Bernstein, MD	Ph:  702-496-2857
			Email: s.yule@sncrf.org
	University Medical Center of Southern Nevada
		Jonathan Bernstein, MD	Ph:  702-496-2857
			Email: s.yule@sncrf.org
New York
	Syracuse
	SUNY Upstate Medical University Hospital
		Irene Cherrick, MD	Ph:  315-464-7601
			Email: cavallem@upstate.edu
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Thomas Williams McLean, MD	Ph:  336-716-9027
			Email: grkeyes@wfubmc.edu
Ohio
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		John Perentesis, MD	Ph:  513-636-9419
			Email: rebecca.turner@cchmc.org
Texas
	San Antonio
	CHRISTUS Santa Rosa Children’s Hospital
		Anne-Marie Langevin, MD	Ph:  210-567-7461
			Email: lewism1@utscsa.edu
Virginia
	Norfolk
	Children's Hospital of The King's Daughters
		Eric Lowe, MD	Ph:  757-668-7909
			Email: sabrina.wigginton@chkd.org

Registry Information
Official Title		Prevention of Cancer/Treatment-Related Weight Loss in Children Receiving Moderately to Highly Emetic Chemotherapy
Trial Start Date		2010-06-01
Trial Completion Date		2014-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT01132547
Date Submitted to PDQ		2010-05-21
Information Last Verified		2011-12-19
NCI Grant/Contract Number		CA81920

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