Status:
TERMINATED
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Anorexia
Cachexia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00637806
Start Date
June 1 2006
End Date
September 1 2006
Last Update
May 2 2016
Active Locations (4)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
Four Seasons Hospice and Paliative Care
Flat Rock, North Carolina, United States, 28731
3
Wake Forest University
High Point, North Carolina, United States, 27262
4
Summit Oncology Associates, Inc.
Akron, Ohio, United States, 44304