Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
Official Title
Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
Acronym
Not provided
Organization
University of South FloridaOTHER
Status Module
Record Verification Date
Jun 2015
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated due to slow accrual.
Expanded Access Info
No
Start Date
Jun 2010
Primary Completion Date
Jan 2014Actual
Completion Date
Jan 2014Actual
First Submitted Date
May 26, 2010
First Submission Date that Met QC Criteria
May 26, 2010
First Posted Date
May 28, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 12, 2015
Results First Submitted that Met QC Criteria
Jun 4, 2015
Results First Posted Date
Jul 2, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 4, 2015
Last Update Posted Date
Jul 2, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of South FloridaOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
22Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I cyproheptadine hydrochloride
Experimental
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
Drug: cyproheptadine hydrochloride
Arm II placebo
Placebo Comparator
Patients receive an oral placebo twice daily for 8 weeks.
Other: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cyproheptadine hydrochloride
Drug
Given orally
Arm I cyproheptadine hydrochloride
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
8 weeks
Severity of Weight Loss
Change from Baseline in Weight Z score
Baseline and 8 weeks
Secondary Outcomes
Measure
Description
Time Frame
Pattern of Weight in the Study Population
Change from Baseline in Weight
Baseline and 8 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility 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