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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


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 Baseline

Severity 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.


Minimum age: 2 Years. Maximum age: 21 Years. Gender(s): Both.



- ≥ 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


- 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


- 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

Page last updated: August 20, 2015

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