Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
Information source: University of South Florida
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: cyproheptadine hydrochloride (Drug); placebo (Other)
Phase: Phase 3
Status: Terminated
Sponsored by: University of South Florida Official(s) and/or principal investigator(s): Jeffrey P. Krischer, PhD, Principal Investigator, Affiliation: University of South Florida
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.
Clinical Details
Official title: Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to BaselineSeverity of Weight Loss
Secondary outcome: Pattern of Weight in the Study Population
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
Minimum age: 2 Years.
Maximum age: 21 Years.
Gender(s): Both.
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.
Locations and Contacts
Miller Children's Hospital, Long Beach, California 90806, United States
Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States
A.I. duPont Hospital for Children, Wilmington, Delaware 19803, United States
Children's National Medical Center, Washington, District of Columbia 20010, United States
Children's Hospital of Southwest Florida at Lee Memorial, Fort Myers, Florida 33908, United States
Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207-8482, United States
Arnold Palmer Hospital for Children, Orlando, Florida 32806, United States
Nemours Children's Clinic - Orlando, Orlando, Florida 32806, United States
Nemours Children's Hospital Pensacola, Pensacola, Florida 32504, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States
Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States
Columbia University Medical Center, New York, New York 10032, United States
CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas 78207, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia 23507, United States
Additional Information
Starting date: June 2010
Last updated: June 4, 2015
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