Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
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
Megestrol acetate concentrated suspension 60 mg/mL
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia focused on measuring Megestrol acetate, Anorexia, Cachexia, Cancer, Unintended weight loss, Body weight, Appetite, Megace ES
Eligibility Criteria
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
Sites / Locations
- Pacific Cancer Medical Center, Inc.
- Four Seasons Hospice and Paliative Care
- Wake Forest University
- Summit Oncology Associates, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Megestrol acetate concentrated suspension 110 mg/mL
Megestrol acetate concentrated suspension 60 mg/mL
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
Change in Weight Over the Course of the 8-week Double-blind Phase
Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
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
NCT ID
NCT00637806
First Posted
March 11, 2008
Last Updated
March 31, 2016
Sponsor
Par Pharmaceutical, Inc.
Collaborators
PRA Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00637806
Brief Title
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 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
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.
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, 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
4 (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
Active Comparator
Arm Description
Megestrol acetate concentrated suspension 60 mg/mL
Arm Title
3
Arm Type
Placebo Comparator
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)
Megestrol acetate concentrated suspension 60 mg/mL
Other Intervention Name(s)
Megace ES
Intervention Description
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
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
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
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 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:
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
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
Janet Bull, MD
Organizational Affiliation
Four Seasons Hospice and Paliative Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veena Charu, MD
Organizational Affiliation
Pacific Cancer Medical Center, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bart Frizzell, MD
Organizational Affiliation
Wake Forest University, Dept of Radiation Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehool Patel, MD
Organizational Affiliation
Summit Oncology Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Four Seasons Hospice and Paliative Care
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
Wake Forest University
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Summit Oncology Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
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