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

This study has been terminated.
(Difficulty finding the required patient population)
PRA Health Sciences
Information provided by (Responsible Party):
Par Pharmaceutical, Inc. Identifier:
First received: March 11, 2008
Last updated: May 18, 2016
Last verified: May 2016
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

Condition Intervention Phase
Weight Loss
Drug: Megestrol acetate concentrated suspension 110 mg/mL
Drug: Placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline [ Time Frame: Baseline, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Change in Weight Over the Course of the 8-week Double-blind Phase [ Time Frame: Baseline, Week 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6 and 8 ] [ Designated as safety issue: No ]
    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

Enrollment: 5
Study Start Date: June 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Megestrol acetate concentrated suspension 110 mg/mL
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
Other Name: Megace ES
Placebo Comparator: 2
Placebo suspension
Drug: Placebo
Placebo oral suspension, 5 mL once daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00637728

United States, Florida
Innovative Medical Research of South Florida, Inc
Miami, Florida, United States, 33179
United States, Maryland
Western Maryland Health System
Cumberland, Maryland, United States, 21502
United States, South Carolina
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Par Pharmaceutical, Inc.
PRA Health Sciences
Study Chair: Lynn D Kramer, MD Par Pharmaceutical, Inc.
Principal Investigator: John N Mehanna, MD Western Maryland Health System
Principal Investigator: M.Daud Nawabi, MD Lowcountry Hematology & Oncology, PA
Principal Investigator: Marc A Saltzman, MD Innovative Medical Research of South Florida, Inc
  More Information

Responsible Party: Par Pharmaceutical, Inc. Identifier: NCT00637728     History of Changes
Other Study ID Numbers: 100.2.C.006 TRANSFERRED 
Study First Received: March 11, 2008
Results First Received: January 29, 2016
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
Megestrol acetate
Lung cancer
Pancreatic cancer
Unintended weight loss
Body weight
Megace ES

Additional relevant MeSH terms:
Pancreatic Neoplasms
Weight Loss
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants processed this record on October 21, 2016