Title
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
A Randomized, Double-blind, Placebo-controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-associated Anorexia in Subjects With Cancer of Multiple Types
Phase
Phase 3Lead Sponsor
Par PharmaceuticalsStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Anorexia Cachexia Weight LossIntervention/Treatment
megestrol ...Study Participants
4To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.
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
Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase
Placebo oral suspension, 5 mL once daily
Megestrol acetate concentrated suspension 110 mg/mL
Megestrol acetate concentrated suspension 60 mg/mL
Inclusion Criteria: Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy Fair, poor, or very poor appetite Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months) Weight loss perceived to be associated with diminished appetite Eastern Cooperative Oncology Group Performance score of 0, 1, or 2 Life expectancy greater than 3 months Alert and mentally competent to complete study assessments Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year Screening laboratory values must not be clinically significant (some exceptions per protocol) Exclusion Criteria: Brain, or head and neck tumors that may interfere with food consumption AIDS-related wasting Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption Presence of conditions that interfere with oral intake or ability to swallow Absence of normally functioning gut Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome Intractable or frequent vomiting Clinically significant diarrhea History of thromboembolic events, or on long-term anticoagulation for thromboembolism Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism Poorly controlled hypertension or congestive heart failure Pregnant/lactating females, or planning on becoming pregnant Use of appetite stimulants within past 30 days Use of parenteral nutrition or tube feedings within past 1 week Chronic use of steroids within past 3 months (intermittent short-term use allowed) Current use of illicit substances Allergy, hypersensitivity, or other contraindication to megestrol acetate
| Event Type | Organ System | Event Term | DB MA-CS 550 mg/Day | DB MA-CS 300 mg/Day | DB Placebo | OL MA-CS 550 mg/Day |
|---|
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.
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
