Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	Megestrol acetate concentrated suspension 110 mg/mL	Megestrol acetate concentrated suspension 110 mg/mL
2	Megestrol acetate concentrated suspension 60 mg/mL	Megestrol acetate concentrated suspension 60 mg/mL

Primary Outcome Measures

Name	Time	Method
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase	8 weeks	The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.

Secondary Outcome Measures

Name	Time	Method
Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale	Baseline, Weeks 1, 2, 3, 4, 6 and 8	Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food
Change in Weight Over the Course of the 8-week Double-blind Phase	Baseline, Week 1, 2, 3, 4, 6, and 8
Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline	Baseline, Week 4 and Week 8

Trial Locations

Locations (4)

Pacific Cancer Medical Center, Inc.

🇺🇸

Anaheim, California, United States

Summit Oncology Associates, Inc.

🇺🇸

Akron, Ohio, United States

Four Seasons Hospice and Paliative Care

🇺🇸

Flat Rock, North Carolina, United States

Wake Forest University

🇺🇸

High Point, North Carolina, United States

Recruitment & Eligibility