Clinical trial NCT00637728: Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anorexia
Cachexia
Weight Loss
Keywords: Megestrol acetate
Anorexia
Cachexia
Lung cancer
Pancreatic 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: 5
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: 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


Eligibility criteria: 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

Primary outcomes:
measure: Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
timeFrame: 8 weeks
Secondary outcomes:
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 Weight Over the Course of the 8-week Double-blind Phase
timeFrame: Baseline, Week 1, 2, 3, 4, 6, and 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: Miami
country: United States
facility: Innovative Medical Research of South Florida, Inc
state: Florida
city: Cumberland
country: United States
facility: Western Maryland Health System
state: Maryland
city: Mt. Pleasant
country: United States
facility: Lowcountry Hematology & Oncology, PA
state: South Carolina
Study officials:
affiliation: Par Pharmaceutical, Inc.
name: Lynn D Kramer, MD
role: STUDY_CHAIR
affiliation: Western Maryland Health System
name: John N Mehanna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lowcountry Hematology & Oncology, PA
name: M.Daud Nawabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovative Medical Research of South Florida, Inc
name: Marc A Saltzman, MD
role: PRINCIPAL_INVESTIGATOR
References: