Clinical trial NCT00637806: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anorexia
Cachexia
Weight Loss
Keywords: Megestrol acetate
Anorexia
Cachexia
Cancer
Unintended weight loss
Body weight
Appetite
Megace ES
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2008-03-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Weight Over the Course of the 8-week Double-blind Phase
timeFrame: Baseline, Week 1, 2, 3, 4, 6, and 8
measure: Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
timeFrame: Baseline, Week 4 and Week 8
measure: Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6 and 8
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Flat Rock
country: United States
facility: Four Seasons Hospice and Paliative Care
state: North Carolina
city: High Point
country: United States
facility: Wake Forest University
state: North Carolina
city: Akron
country: United States
facility: Summit Oncology Associates, Inc.
state: Ohio
Study officials:
affiliation: Par Pharmaceutical, Inc.
name: Lynn D Kramer, MD
role: STUDY_CHAIR
affiliation: Four Seasons Hospice and Paliative Care
name: Janet Bull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Cancer Medical Center, Inc.
name: Veena Charu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University, Dept of Radiation Oncology
name: Bart Frizzell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summit Oncology Associates, Inc.
name: Mehool Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: