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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Anorexia Cachexia Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Megestrol acetate concentrated suspension 110 mg/mL

Group Type ACTIVE_COMPARATOR

Megestrol acetate concentrated suspension 110 mg/mL

Intervention Type DRUG

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

2

Placebo suspension

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral suspension, 5 mL once daily

Interventions

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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

Intervention Type DRUG

Placebo

Placebo oral suspension, 5 mL once daily

Intervention Type DRUG

Other Intervention Names

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Megace ES

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No