Treatment of Cancer-Associated Anorexia Using Megestrol Acetate Concentrated Suspension

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 Cancer of Multiple Types

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637806
• Other study ID #: 100.2.C.005
• Status: Terminated
• Phase: Phase 3
• First received: March 11, 2008
• Last updated: March 11, 2008
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: March 2008
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• 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:

• 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 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
• 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
• 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
• Placebo
Placebo oral suspension, 5 mL once daily

Locations

Country	Name	City	State
United States	Summit Oncology Associates, Inc.	Akron	Ohio
United States	Pacific Cancer Medical Center, Inc.	Anaheim	California
United States	Four Seasons Hospice and Paliative Care	Flat Rock	North Carolina
United States	Wake Forest University	High Point	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caloric intake		Daily	No
Secondary	Weight		Weekly	No
Secondary	Patient reported appetite		Weekly	No
Secondary	Body composition		Weekly	No