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

Primary Purpose

Anorexia, Cachexia, Weight Loss

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Megestrol acetate concentrated suspension 110 mg/mL
Placebo
Sponsored by
Par Pharmaceutical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia focused on measuring Megestrol acetate, Anorexia, Cachexia, Lung cancer, Pancreatic cancer, Unintended weight loss, Body weight, Appetite, Megace ES

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Innovative Medical Research of South Florida, Inc
  • Western Maryland Health System
  • Lowcountry Hematology & Oncology, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Megestrol acetate concentrated suspension 110 mg/mL

Placebo suspension

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
Change in Weight Over the Course of the 8-week Double-blind Phase
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

Full Information

First Posted
March 11, 2008
Last Updated
May 18, 2016
Sponsor
Par Pharmaceutical, Inc.
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00637728
Brief Title
Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty finding the required patient population
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Par Pharmaceutical, Inc.
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Cachexia, Weight Loss
Keywords
Megestrol acetate, Anorexia, Cachexia, Lung cancer, Pancreatic cancer, Unintended weight loss, Body weight, Appetite, Megace ES

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Megestrol acetate concentrated suspension 110 mg/mL
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo suspension
Intervention Type
Drug
Intervention Name(s)
Megestrol acetate concentrated suspension 110 mg/mL
Other Intervention Name(s)
Megace ES
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral suspension, 5 mL once daily
Primary Outcome Measure Information:
Title
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Title
Change in Weight Over the Course of the 8-week Double-blind Phase
Time Frame
Baseline, Week 1, 2, 3, 4, 6, and 8
Title
Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale
Description
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
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn D Kramer, MD
Organizational Affiliation
Par Pharmaceutical, Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John N Mehanna, MD
Organizational Affiliation
Western Maryland Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M.Daud Nawabi, MD
Organizational Affiliation
Lowcountry Hematology & Oncology, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc A Saltzman, MD
Organizational Affiliation
Innovative Medical Research of South Florida, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovative Medical Research of South Florida, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Western Maryland Health System
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Lowcountry Hematology & Oncology, PA
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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