Trial intelligence / Profile preview

Cyproheptadine and Megestrol for Cancer Cachexia in Children

NCT00066248Phase 2

Key facts

Status: Completed
Start: Jun 2003
Primary completion: Aug 2007
Countries: 3
Sponsor: University of South Florida
Modality: Small Molecules

Drugs: cyproheptadinemegestrol
Conditions: cachexia

Overview

Phase 2, open-label trial of cyproheptadine and megestrol in cachexia (2 arms), sponsored by University of South Florida. Primary endpoint: Change in weight at 4 weeks. Started Jun 2003; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Cyproheptadine Responders
Patients who respond to Cyproheptadine (stable or increased weight) and go off study or continue at physician discretion.
Cyproheptadine Non-Responders
Patients who do not respond to Cyproheptadine (weight loss) and switch to Megestrol Acetate.

Who it enrols

Children and young adults (2-21 years) with cancer or treatment-related cachexia (weight loss >5% or growth failure). Excludes patients with hormone-sensitive tumors, neurofibromatosis, glaucoma, asthma, GI/GU obstruction, hypertension, thromboembolic disease, or recent use of appetite stimulants.

Endpoints

Primary

Change in weight4 weeks

Secondary

Pre-albumin levels4 weeks
Lipid profile4 weeks

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