Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

This study has been terminated.
(Difficulty finding the required patient population)
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00637806
First received: March 11, 2008
Last updated: March 31, 2016
Last verified: March 2016
  Purpose
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Condition Intervention Phase
Anorexia
Cachexia
Weight Loss
Drug: Megestrol acetate concentrated suspension 110 mg/mL
Drug: Megestrol acetate concentrated suspension 60 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 Cancer of Multiple Types

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:
  • 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 ]
  • 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 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: 4
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
Active Comparator: 2
Megestrol acetate concentrated suspension 60 mg/mL
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
Other Name: Megace ES
Placebo Comparator: 3 Drug: Placebo
Placebo oral suspension, 5 mL once daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637806

Locations
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
United States, North Carolina
Four Seasons Hospice and Paliative Care
Flat Rock, North Carolina, United States, 28731
Wake Forest University
High Point, North Carolina, United States, 27262
United States, Ohio
Summit Oncology Associates, Inc.
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Par Pharmaceutical, Inc.
PRA Health Sciences
Investigators
Study Chair: Lynn D Kramer, MD Par Pharmaceutical, Inc.
Principal Investigator: Janet Bull, MD Four Seasons Hospice and Paliative Care
Principal Investigator: Veena Charu, MD Pacific Cancer Medical Center, Inc.
Principal Investigator: Bart Frizzell, MD Wake Forest University, Dept of Radiation Oncology
Principal Investigator: Mehool Patel, MD Summit Oncology Associates, Inc.
  More Information

Responsible Party: Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00637806     History of Changes
Other Study ID Numbers: 100.2.C.005 TRANSFERRED 
Study First Received: March 11, 2008
Results First Received: January 29, 2016
Last Updated: March 31, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
Megestrol acetate
Anorexia
Cachexia
Cancer
Unintended weight loss
Body weight
Appetite
Megace ES

Additional relevant MeSH terms:
Weight Loss
Anorexia
Cachexia
Body Weight Changes
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Emaciation
Megestrol
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

ClinicalTrials.gov processed this record on August 25, 2016