Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyproheptadine

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.