Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

NCT ID: NCT00637806

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2006-09-30

Brief Summary

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

Conditions

Anorexia; Cachexia; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Megestrol acetate concentrated suspension 110 mg/mL

Group Type: ACTIVE_COMPARATOR

Megestrol acetate concentrated suspension 110 mg/mL

Intervention Type: DRUG

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

2

Megestrol acetate concentrated suspension 60 mg/mL

Group Type: ACTIVE_COMPARATOR

Megestrol acetate concentrated suspension 60 mg/mL

Intervention Type: DRUG

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

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral suspension, 5 mL once daily

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo

Placebo oral suspension, 5 mL once daily

Intervention Type: DRUG

Other Intervention Names

Megace ES; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

Par Pharmaceutical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn D Kramer, MD

Role: STUDY_CHAIR

Par Pharmaceutical, Inc.

Janet Bull, MD

Role: PRINCIPAL_INVESTIGATOR

Four Seasons Hospice and Paliative Care

Veena Charu, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Cancer Medical Center, Inc.

Bart Frizzell, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University, Dept of Radiation Oncology

Mehool Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Summit Oncology Associates, Inc.

Locations

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, United States

Summit Oncology Associates, Inc.

Akron, Ohio, United States

Countries

United States

Other Identifiers

100.2.C.005 TRANSFERRED

Identifier Type: -

Identifier Source: org_study_id