Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
Condition: Anorexia; Cachexia; Weight Loss
MeSH terms: Wasting Syndrome; Weight Loss; Anorexia; Cachexia
Intervention: Megestrol acetate concentrated suspension 110 mg/mL; Megestrol acetate concentrated suspension 60 mg/mL; Placebo
Intervention description: 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
Intervention MeSH terms: Megestrol; Megestrol Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Megestrol acetate; Anorexia; Cachexia; Cancer; Unintended weight loss; Body weight; Appetite; Megace ES

Summary:

      To compare the effect of megestrol acetate concentrated suspension and placebo on caloric
      intake in patients with cancer-associated anorexia.
    

Eligibility criteria:

        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