Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

This study has been terminated.
(The study was terminated due to slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01132547
First received: May 26, 2010
Last updated: January 31, 2014
Last verified: January 2014
  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:

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

Further study details as provided by University of South Florida:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Severity of weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pattern of weight in the study population [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison on the change for prealbumin of malnourishment and body composition between groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison of the effect of cyproheptadine hydrochloride on prealbumin levels of malnourishment and on body composition within the treatment group at completion of therapy, baseline, and post-intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison of the changes between those with and without weight loss within treatment groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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
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
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Arnold Palmer Hospital for Children
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
Investigators
Principal Investigator: Jeffrey P. Krischer, PhD University of South Florida
  More Information

No publications provided

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
Last Updated: January 31, 2014
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 pilocytic astrocytoma
untreated childhood pilocytic 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
Therapeutic Uses
Pharmacologic Actions
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 18, 2014