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SCUSF 0703 Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk [ACCL0935]

Study Chair: 
Marisa Couluris, D.O.
 
Status:

NCI Approved
Activation date: 6/01/2010
NCT01132547

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.
  • 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.

Subject Selection

Inclusion Criteria:

  • Patients must be between 2 and 21 years of age at the time of study entry
  • Scheduled to receive chemotherapy for newly diagnosed:
      • Non-rhabdo soft tissue sarcomas, 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 starting chemotherapy (registration / randomization and start of study agent may occur at any time up to and including Day 28 after the initiation of chemotherapy.
Exclusion Criteria:
  • > 29 days after the start of chemotherapy
  • Documented history of unintended weight loss greater or equal to 5% presumed secondary to cancer within the last 3 months
  • BMI for age percentile are greater than or equal to the 95th percentile at registration
  • 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. 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.

Link to Abstract [.pdf]

 

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U.S. Department of Health & Human Services National Institutes of Health (NIH) National Cancer Institute