Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

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

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

Study Overview

• Status: Terminated
• Conditions: Anorexia; Weight Loss; Cachexia
• Intervention / Treatment: Drug: Megestrol acetate concentrated suspension 110 mg/mL; Drug: Megestrol acetate concentrated suspension 60 mg/mL; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center, Inc.
  • North Carolina
    • Flat Rock, North Carolina, United States, 28731
      • Four Seasons Hospice and Paliative Care
    • High Point, North Carolina, United States, 27262
      • Wake Forest University
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summit Oncology Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3	Drug: Placebo; Placebo oral suspension, 5 mL once daily
Active Comparator: 1; Megestrol acetate concentrated suspension 110 mg/mL	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
Active Comparator: 2; Megestrol acetate concentrated suspension 60 mg/mL	Drug: Megestrol acetate concentrated suspension 60 mg/mL; 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; Other Names: Megace ES

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: PRA Health Sciences
• Investigators: Study Chair: Lynn D Kramer, MD, Par Pharmaceutical, Inc.; Principal Investigator: Janet Bull, MD, Four Seasons Hospice and Paliative Care; Principal Investigator: Veena Charu, MD, Pacific Cancer Medical Center, Inc.; Principal Investigator: Bart Frizzell, MD, Wake Forest University, Dept of Radiation Oncology; Principal Investigator: Mehool Patel, MD, Summit Oncology Associates, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; Cachexia; Anorexia; Appetite; Body weight; Megace ES; Megestrol acetate; Unintended weight loss
• Additional Relevant MeSH Terms: Metabolic Diseases; Signs and Symptoms, Digestive; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Anorexia; Weight Loss; Wasting Syndrome; Cachexia; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Central Nervous System Stimulants; Appetite Stimulants; Megestrol; Megestrol Acetate
• Other Study ID Numbers: 100.2.C.005 TRANSFERRED