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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637728
Recruitment Status : Terminated (Difficulty finding the required patient population)
First Posted : March 18, 2008
Results First Posted : February 29, 2016
Last Update Posted : June 23, 2016
PRA Health Sciences
Information provided by (Responsible Party):
Par Pharmaceutical, Inc.

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

Condition or disease Intervention/treatment Phase
Anorexia Cachexia Weight Loss Drug: Megestrol acetate concentrated suspension 110 mg/mL Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase [ Time Frame: 8 weeks ]
    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 :
  1. 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 ]
  2. Change in Weight Over the Course of the 8-week Double-blind Phase [ Time Frame: Baseline, Week 1, 2, 3, 4, 6, and 8 ]
  3. 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637728

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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
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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

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Responsible Party: Par Pharmaceutical, Inc. Identifier: NCT00637728    
Other Study ID Numbers: 100.2.C.006 TRANSFERRED
First Posted: March 18, 2008    Key Record Dates
Results First Posted: February 29, 2016
Last Update Posted: June 23, 2016
Last Verified: May 2016
Keywords provided by Par Pharmaceutical, Inc.:
Megestrol acetate
Lung cancer
Pancreatic cancer
Unintended weight loss
Body weight
Megace ES
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Wasting Syndrome
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
Metabolic Diseases
Nutrition Disorders
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