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

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Official Title:	Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

Resource links provided by NLM:

Genetics Home Reference related topics: Ewing sarcoma neuroblastoma

MedlinePlus related topics: Body Weight Cancer Weight Control

Drug Information available for: Cyproheptadine Cyproheptadine hydrochloride

Genetic and Rare Diseases Information Center resources: Glioma Lymphosarcoma Kidney Cancer Renal Cancer Glioblastoma Neuroblastoma Myeloid Leukemia Bone Cancer Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Brain Tumor, Childhood Lymphoma, Large-cell Malignant Mesenchymal Tumor Soft Tissue Sarcoma Oligodendroglioma Oligoastrocytoma Anaplastic Large Cell Lymphoma Testicular Cancer Acute Promyelocytic Leukemia Ewing Sarcoma Ewing's Family of Tumors Anaplastic Astrocytoma Osteosarcoma Synovial Sarcoma Medulloblastoma Malignant Mixed Mullerian Tumor Uterine Carcinosarcoma Anaplastic Oligodendroglioma Wilms' Tumor Alveolar Soft Part Sarcoma Hepatoblastoma Meningioma Acute Erythroid Leukemia Neuroepithelioma Liposarcoma Ovarian Germ Cell Tumor Nonseminomatous Germ Cell Tumor Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Chondrosarcoma Anaplastic Oligoastrocytoma Gliosarcoma Optic Pathway Glioma Ependymoma Medulloblastoma, Childhood Ovarian Carcinosarcoma Embryonal Tumor With Multilayered Rosettes Epithelioid Sarcoma Leiomyosarcoma Fibrosarcoma Acute Megakaryoblastic Leukemia Acute Myelomonocytic Leukemia Di Guglielmo's Syndrome Acute Monoblastic Leukemia Childhood Brain Stem Glioma Malignant Germ Cell Tumor Pilocytic Astrocytoma Cerebellar Astrocytoma, Childhood Supratentorial Primitive Neuroectodermal Tumors, Childhood Cerebral Astrocytoma, Childhood Gliomatosis Cerebri Supratentorial Primitive Neuroectodermal Tumor Diffuse Astrocytoma Subependymal Giant Cell Astrocytoma Pleomorphic Xanthoastrocytoma Endometrial Stromal Sarcoma Uterine Sarcoma Extragonadal Germ Cell Tumor

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:

Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Severity of Weight Loss [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Weight Z score

Secondary Outcome Measures:

Pattern of Weight in the Study Population [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Weight


Enrollment:	22
Study Start Date:	June 2010
Study Completion Date:	January 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	2 Years to 21 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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


Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT01132547 History of Changes
Other Study ID Numbers:	SCUSF 0703 SCUSF-0703 5U10CA081920-11
Study First Received:	May 26, 2010
Results First Received:	January 12, 2015
Last Updated:	June 4, 2015
Health Authority:	United States: Data and Safety Monitoring Board United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2016