Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
This study is currently recruiting participants.
Verified May 2013 by University of South Florida
Sponsor:
University of South Florida
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01132547
First received: May 26, 2010
Last updated: June 3, 2013
Last verified: May 2013
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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:
acute promyelocytic leukemia
Ewing sarcoma
familial acute myeloid leukemia with mutated CEBPA
neuroblastoma
MedlinePlus related topics:
Cancer
Leukemia
Lymphoma
Nausea and Vomiting
Neuroblastoma
Soft Tissue Sarcoma
Testicular Cancer
Weight Control
Wilms' Tumor
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 ]
| 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132547
Contacts
| Contact: Nina Naas, MPH, CPH | 813-396-9502 | Nina.Naas@epi.usf.edu |
Locations
| United States, California | |
| Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90806 | |
| Contact: Amanda Termuhlen, MD 562-933-8626 ATermuhlen@memorialcare.org | |
| Principal Investigator: Amanda Termuhlen, MD | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Andrea Orsey, MD 860-545-9630 Aorsey@ccmckids.org | |
| Principal Investigator: Andrea Orsey, MD | |
| United States, Florida | |
| 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 - Jacksonville | 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 | |
| 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, 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
Investigators
| Principal Investigator: | Jeffrey P. Krischer, PhD | University of South Florida |
More Information
Additional 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: | June 3, 2013 |
| 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:
|
childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma 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 |
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 June 18, 2013