Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Par Pharmaceutical, Inc.
With
PRA Health Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
