Clinical Trial: Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

Brief 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.


Detailed Summary:

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 measur
Sponsor: University of South Florida

Current Primary Outcome:

  • Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline [ Time Frame: 8 weeks ]
  • Severity of Weight Loss [ Time Frame: Baseline and 8 weeks ]
    Change from Baseline in Weight Z score


Original Primary Outcome:

  • Incidence rate at the end of 16 weeks
  • Severity of Weight Loss


Current Secondary Outcome: Pattern of Weight in the Study Population [ Time Frame: Baseline and 8 weeks ]

Change from Baseline in Weight


Original Secondary Outcome:

  • Pattern of Weight in the Study Population
  • Duration of response
  • Comparison on the change for each biomarker (prealbumin and transferrin) of malnourishment and body composition between groups
  • Comparison of the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition within the treatment group at completion of therapy, baseline, and post-intervention
  • Comparison of the changes between those with and without weight loss within treatment groups
  • Adverse events


Information By: University of South Florida

Dates:
Date Received: May 26, 2010
Date Started: June 2010
Date Completion:
Last Updated: June 4, 2015
Last Verified: June 2015