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

    Phase 3
  • Study Type

  • Intervention/Treatment

    megestrol ...
  • Study Participants

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
Study Started
Jun 30
Primary Completion
Sep 30
Study Completion
Sep 30
Results Posted
Feb 29
Last Update
Jun 23

Drug Megestrol acetate concentrated suspension 110 mg/mL

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

  • Other names: Megace ES

Drug Placebo

Placebo oral suspension, 5 mL once daily

1 Active Comparator

Megestrol acetate concentrated suspension 110 mg/mL

2 Placebo Comparator

Placebo suspension


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


DB MA-CS 550 mg/Day

DB Placebo

OL MA-CS 550 mg/Day

All Events

Event Type Organ System Event Term DB MA-CS 550 mg/Day DB Placebo OL MA-CS 550 mg/Day

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.

DB MA-CS 550 mg/Day

DB Placebo

Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline

DB MA-CS 550 mg/Day

DB Placebo

Change in Weight Over the Course of the 8-week Double-blind Phase

DB MA-CS 550 mg/Day

DB Placebo

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

DB MA-CS 550 mg/Day

DB Placebo



Age, Categorical

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Double-blind Phase

DB MA-CS 550 mg/Day

DB Placebo

Drop/Withdrawal Reasons

DB MA-CS 550 mg/Day

DB Placebo