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

May 18, 2016 updated by: Par Pharmaceutical, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33179
        • Innovative Medical Research of South Florida, Inc
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Western Maryland Health System
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Lowcountry Hematology & Oncology, Pa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Placebo Comparator: 2
Placebo suspension
Drug: Placebo
Placebo oral suspension, 5 mL once daily

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
Time Frame: 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.
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Par Pharmaceutical, Inc.

Collaborators

PRA Health Sciences

Investigators

  • Study Chair: Lynn D Kramer, MD, Par Pharmaceutical, Inc.
  • Principal Investigator: John N Mehanna, MD, Western Maryland Health System
  • Principal Investigator: M.Daud Nawabi, MD, Lowcountry Hematology & Oncology, Pa
  • Principal Investigator: Marc A Saltzman, MD, Innovative Medical Research of South Florida, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

June 23, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100.2.C.006 TRANSFERRED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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