Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00637806
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00637806
Study Brief:
Protocol Section:
NCT00637806