Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
Placebo oral suspension, 5 mL once daily
Innovative Medical Research of South Florida, Inc
Miami, Florida, United States
Western Maryland Health System
Cumberland, Maryland, United States
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, United States
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.
Time frame: 8 weeks
Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
Time frame: Baseline, Week 4 and Week 8
Change in Weight Over the Course of the 8-week Double-blind Phase
Time frame: Baseline, Week 1, 2, 3, 4, 6, and 8
Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale
Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food
Time frame: Baseline, Weeks 1, 2, 3, 4, 6 and 8
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