Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer - Full Text View

Purpose

RATIONALE: Cyproheptadine 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 to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.

Condition	Intervention	Phase
Cancer	Drug: cyproheptadine hydrochloride Other: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
Official Title:	Prevention of Cancer/Treatment-Related Weight Loss in Children Receiving Moderately to Highly Emetic Chemotherapy

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: Yes ]
Severity of weight loss [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pattern of weight in the study population [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]
Comparison on the change for each biomarker (prealbumin and transferrin) of malnourishment and body composition between groups [ Designated as safety issue: No ]
Comparison of the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition within the treatment group at completion of therapy, baseline, and post-intervention [ Designated as safety issue: No ]
Comparison of the changes between those with and without weight loss within treatment groups [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment:	178
Study Start Date:	June 2010
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.	Drug: cyproheptadine hydrochloride Given orally
Placebo Comparator: Arm II Patients receive an oral placebo twice daily for 8 weeks.	Other: placebo Given orally

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 assess the pattern of weight change between two groups (treatment vs placebo) during the study.
To investigate the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition between two groups at completion of therapy compared to baseline measures.
To investigate the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition within the treatment group at completion of therapy compared to baseline measures, specifically those patients with no weight loss as compared to those patients who experience weight loss.

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.

Eligibility

Ages Eligible for Study:	2 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)
Scheduled to receive moderately or highly emetic chemotherapy as outlined in the 2006 ASCO Recommendations
- Patients on multi-drug regimens, with varying emetic potential, are classified according to the agent with the highest emetic potential
No documented unintended weight loss of > 5% presumed secondary to cancer within the past 3 months

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Fertile patients must use effective contraception
No history of anorexia nervosa or bulimia
No allergy to cyproheptadine hydrochloride
No diagnoses of glaucoma or gastrointestinal/genitourinary obstruction

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 concurrent rescue/salvage therapy, i.e., other appetite stimulants, enteral tube feedings, or initiation of total parenteral nutrition (TPN), prior to study week 8
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
Other forms of nutritional therapies, e.g., appetite-stimulating medications, TPN, or enteral tube feedings are not allowed during this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132547

Locations

United States, California
Kaiser Permanente Medical Center - Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Contact: Robert Cooper, MD, CCRP 323-783-8831 olga.e.osuna@kp.org
United States, Delaware
Alfred I. duPont Hospital for Children	Recruiting
Wilmington, Delaware, United States, 19899
Contact: Gregory C. Griffin, MD 302-651-5528 pcawood@nemours.org
United States, Florida
Broward General Medical Center Cancer Center	Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Hector Rodriguez-Cortes, MD 954-355-5488 cdiazpowsang@browardhealth.org
Children's Hospital of Southwest Florida	Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman, MD 239-343-6959 carolyn.bell@leememorial.org
Nemours Children's Clinic	Recruiting
Jacksonville, Florida, United States, 32207-8482
Contact: Eric Sandler, MD 904-697-3817 mbarry@nemours.org
Nemours Children's Clinic - Orlando	Recruiting
Orlando, Florida, United States, 32806
Contact: Paul Gordon, MD 407-650-7652 krwilson@nemours.org
Arnold Palmer Hospital for Children	Recruiting
Orlando, Florida, United States, 32806
Contact: Don E. Eslin, MD 321-841-3837 stephanie.garber@orlandohealth.com
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org
United States, Hawaii
Kapiolani Medical Center for Women and Children	Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Robert W. Wilkinson, MD 808-586-2979 emelie@crch.hawaii.edu
United States, Mississippi
University of Mississippi Cancer Clinic	Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason, MD 601-984-5224 rlowery@umc.edu
United States, Nevada
CCOP - Nevada Cancer Research Foundation	Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein, MD 702-496-2857 s.yule@sncrf.org
Sunrise Hospital and Medical Center	Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Jonathan Bernstein, MD 702-496-2857 s.yule@sncrf.org
University Medical Center of Southern Nevada	Recruiting
Las Vegas, Nevada, United States, 89102-2386
Contact: Jonathan Bernstein, MD 702-496-2857 s.yule@sncrf.org
United States, New York
SUNY Upstate Medical University Hospital	Recruiting
Syracuse, New York, United States, 13210
Contact: Irene Cherrick, MD 315-464-7601 cavallem@upstate.edu
United States, North Carolina
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1081
Contact: Thomas Williams McLean, MD 336-716-9027 grkeyes@wfubmc.edu
United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: John P. Perentesis, MD 513-636-9419 rebecca.turner@cchmc.org
United States, Texas
CHRISTUS Santa Rosa Children's Hospital	Recruiting
San Antonio, Texas, United States, 78207
Contact: Anne-Marie Langevin, MD 210-567-7461 lewism1@utscsa.edu
United States, Virginia
Children's Hospital of The King's Daughters	Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric Lowe, MD 757-668-7909 sabrina.wigginton@chkd.org

Sponsors and Collaborators

University of South Florida

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jeffrey P. Krischer, MD, PhD

University of South Florida

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT01132547 History of Changes
Other Study ID Numbers:	CDR0000587488, SCUSF-0703, MCC-0703
Study First Received:	May 26, 2010
Last Updated:	July 26, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

childhood epithelioid sarcoma
cachexia
weight changes
nausea and vomiting
alveolar childhood rhabdomyosarcoma
anaplastic osteosarcoma
childhood alveolar soft-part sarcoma
childhood angiosarcoma
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/peripheral primitive neuroectodermal tumor
localized osteosarcoma
mast cell sarcoma
metastatic childhood soft tissue sarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic osteosarcoma
mixed childhood rhabdomyosarcoma
mixed osteosarcoma

Additional relevant MeSH terms:

Weight Loss
Astrocytoma
Neuroectodermal Tumors, Primitive
Lymphoma, Large-Cell, Anaplastic
Neuroectodermal Tumors, Primitive, Peripheral
Body Weight Changes
Body Weight
Signs and Symptoms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyproheptadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013