Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

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

Official Title
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A Randomized, Double-blind, Placebo-controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-associated Anorexia in Subjects With Cancer of Multiple Types

Conditions
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Anorexia, Cachexia, Weight Loss

Intervention / Treatment
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* Drug: Megestrol acetate concentrated suspension 110 mg/mL
* Drug: Megestrol acetate concentrated suspension 60 mg/mL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Megestrol acetate concentrated suspension 110 mg/mL | Drug: Megestrol acetate concentrated suspension 110 mg/mL<br>* 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<br>* Other names: Megace ES;|
| Active Comparator: 2<br>Megestrol acetate concentrated suspension 60 mg/mL | Drug: Megestrol acetate concentrated suspension 60 mg/mL<br>* 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<br>* Other names: Megace ES;|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo oral suspension, 5 mL once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale | 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 | Baseline, Weeks 1, 2, 3, 4, 6 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Megestrol acetate, Anorexia, Cachexia, Cancer, Unintended weight loss, Body weight, Appetite, Megace ES