Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT01132547

Run by

University of South Florida

People needed

22

Starts

2010-06-01

Expected to finish

2014-01-01

Last updated by the study team

2015-07-02

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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)

You may not qualify if…

• ≥ 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.

Where it is running

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

Full record on ClinicalTrials.gov

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