Microsoft word - 0703 abstract 1-15-10

Title: Prevention of Cancer/Treatment-Related Weight Loss in Children with
Cancers Associated with a High Nutritional Risk- HLMCC 0703 [ACCL0935]

Study Chair:

Study Co-Chair:

Planned Accrual:
Study Objectives:
The primary objective of this study is to determine the effect of cyproheptadine HCl (Periactin®), compared to placebo, on weight during chemotherapy in children with solid tumors that are associated with high nutritional risk. The secondary objectives of this study are 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. Describe the change in pre-albumin, triceps skin fold, mid-arm circumference, and weight loss from baseline to end of treatment in each group (treatment and placebo) separately. Patient population:
Inclusion Criteria:
 Scheduled to receive chemotherapy for newly diagnosed: Intermediate and high-risk rhabdomyosarcoma Intermediate and high-risk neuroblastoma  Patients must be ≥ 2 and ≤ 21 years of age at the time of study entry  Able to register and randomize within 14 days starting chemotherapy (registration / randomization and start of study agent may occur at anytime up to and including Day 14 after the initiation of chemotherapy  More than 14 days after the start of chemotherapy  Patients with a documented history of unintended weightloss > 5% presumed secondary  Patients whose BMI for age percentile are greater than or equal to the 95th percentile at  Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl during the three week period prior to study registration)  History of anorexia nervosa or bulimia  Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine, or paroxetine  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,) or other forms of nutrition therapies, e.g. TPN or enteral tube feedings are not allowed during this study)  Children receiving steroids as part of their chemotherapy treatment regimen are excluded from participation. However, intermittent steroid use for antiemetic regimen is allowed during the study.  Initiation of other forms of nutrition therapies, e.g. TPN or enteral tube feedings  Diagnosed with glaucoma, or GI/GU obstruction, inflammatory bowel disease, Cystic
Treatment Plan:
This is a double-blinded, randomized Phase III study of cyproheptadine hydrochloride (Periactin®) versus placebo for prevention of cancer/treatment-related weight loss in 178 pediatric patients with solid tumors associated with high nutritional risk scheduled to receive chemotherapy. Participants will be stratified by use of steroids in antiemetic regimens during treatment.
Study Endpoints:

The primary endpoint will be the incidence of weight loss (> 5% from baseline) at week 8. The secondary endpoints will include change in body composition, weight, and pre-albumin measure from baseline until the end of study. Informed Consent
Registration & Randomization
1 Initiate cyproheptadine hydrochloride (Periactin®) or placebo twice daily for 8 weeks Baseline:
Follow-up Assessment Week 4
Off-Study (week 8)
Off-Study (week 8)
1. Cyproheptadine hydrochloride (CH) and placebo, supplied by the Moffitt CCOP Research Base, must
start within 14 days of the initial dose of chemotherapy. Study agent will be dosed according to
age. Children 2-6 years of age will receive 2 capsules twice daily delivering 4 mg of cyproheptadine
hydrochloride (2 mg twice daily -1 mg per capsule). Children >6 years of age will receive 2 capsules
twice daily delivering 8 mg of cyproheptadine hydrochloride (4 mg twice daily – 2 mg per capsule).
2 Administration of rescue/salvage therapy, i.e. other appetite stimulants, enteral tube feedings, or initiation of TPN, prior to study week 8, requires that study agent be discontinued.

Source: http://ccop.epi.usf.edu/documents/0703Abstract.pdf