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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637728
• Other study ID #: 100.2.C.006
• Status: Terminated
• Phase: Phase 3
• First received: March 11, 2008
• Last updated: January 29, 2016
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2016
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Cachexia
• Pancreatic Neoplasms
• Weight Loss

Intervention

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
• Placebo
Placebo oral suspension, 5 mL once daily

Locations

Country	Name	City	State
United States	Western Maryland Health System	Cumberland	Maryland
United States	Innovative Medical Research of South Florida, Inc	Miami	Florida
United States	Lowcountry Hematology & Oncology, PA	Mt. Pleasant	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Endo Pharmaceuticals	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in Weight Over the Course of the 8-week Double-blind Phase		Baseline, Week 1, 2, 3, 4, 6, and 8	No
Secondary	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	No