Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Cancer Clinical Trial

Official title:

Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01132547
• Other study ID #: SCUSF 0703
• Secondary ID: SCUSF-07035U10CA
• Status: Terminated
• Phase: Phase 3
• First received: May 26, 2010
• Last updated: June 4, 2015
• Start date: June 2010
• Est. completion date: January 2014

Study information

• Verified date: June 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• cyproheptadine hydrochloride
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Children's Hospital of Southwest Florida at Lee Memorial	Fort Myers	Florida
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Nemours Children's Clinic - Jacksonville	Jacksonville	Florida
United States	Miller Children's Hospital	Long Beach	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia
United States	Arnold Palmer Hospital for Children	Orlando	Florida
United States	Nemours Children's Clinic - Orlando	Orlando	Florida
United States	Nemours Children's Hospital Pensacola	Pensacola	Florida
United States	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas
United States	Children's National Medical Center	Washington	District of Columbia
United States	A.I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant With Weight Loss = 5% at the 8- Week Assessment When Compared to Baseline		8 weeks	Yes
Primary	Severity of Weight Loss	Change from Baseline in Weight Z score	Baseline and 8 weeks	No
Secondary	Pattern of Weight in the Study Population	Change from Baseline in Weight	Baseline and 8 weeks	No