Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreati… (NCT00637728) | Clinical Trial Compass
TerminatedPhase 3
Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients
Stopped: Difficulty finding the required patient population
United States5 participantsStarted 2006-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase