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
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