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

Phase 3

Terminated

• Conditions: Anorexia; Cachexia; Weight Loss
• Interventions: Drug: Megestrol acetate concentrated suspension 110 mg/mL; Drug: Placebo

• Registration Number: NCT00637728
• Lead Sponsor: Par Pharmaceutical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-18
• Results First Submitted: 2016-01-29
• Results First Submitted QC: 2016-01-29
• Results First Posted: 2016-02-29
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

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
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

Trial Locations

Locations (3)

Innovative Medical Research of South Florida, Inc; 🇺🇸 Miami, Florida, United States

Western Maryland Health System; 🇺🇸 Cumberland, Maryland, United States

Lowcountry Hematology & Oncology, PA; 🇺🇸 Mt. Pleasant, South Carolina, United States