Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients

Study Overview
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Brief Summary
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Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer

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 Lung or Pancreatic Cancer

Conditions
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Anorexia, Cachexia, Weight Loss

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage II, III,or IV lung or pancreatic cancer Fair, poor, or very poor appetite Cancer associated anorexia/cachexia Weight loss perceived to be associated with diminished appetite Eastern Cooperative Oncology Group Performance score of 0, 1, 2 Life expectancy >3 months Alert and mentally competent 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 metastases that may interfere with food consumption AIDS-related wasting Radiation therapy to the head and neck, abdomen, or pelvis within past 6 weeks, or anticipated during course of the study such that the result may interfere with food consumption Conditions that interfere with oral intake, or ability to swallow Absence of a normally functioning gut Mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome Intractable or frequent vomiting that regularly interfere with eating Clinically significant diarrhea History of recurrent thromboembolic events, a thromboembolic event in past 3 months, or long-term anticoagulation treatment for thromboembolism Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism Poorly controlled hypertension, or congestive heart failure Pregnant/lactating females Use within past 30 days of an appetite stimulant Use within past week, or planned use during the study of parenteral nutrition or tube feedings Chronic use of steroids within past 3 months (intermittent short-term use allowed) Current use of or not willing to abstain from using illicit substances Allergy, hypersensitivity, or 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;|
| Placebo Comparator: 2<br>Placebo suspension | 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 |
| --- | --- | --- |
| 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 Weight Over the Course of the 8-week Double-blind Phase |  | Baseline, Week 1, 2, 3, 4, 6, and 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, Lung cancer, Pancreatic cancer, Unintended weight loss, Body weight, Appetite, Megace ES