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Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

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ClinicalTrials.gov Identifier: NCT01132547
Recruitment Status : Terminated (The study was terminated due to slow accrual.)
First Posted : May 28, 2010
Results First Posted : July 2, 2015
Last Update Posted : July 2, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Study Description
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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
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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

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
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