Anorexia, Cachexia, Weight Loss
Conditions
Keywords
Megestrol acetate, Anorexia, Cachexia, Lung cancer, Pancreatic cancer, Unintended weight loss, Body weight, Appetite, Megace ES
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
Interventions
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
DRUGPlacebo
Placebo oral suspension, 5 mL once daily
Sponsors
PRA Health Sciences
Par Pharmaceutical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline | Baseline, Week 4 and Week 8 | — |
| Change in Weight Over the Course of the 8-week Double-blind Phase | Baseline, Week 1, 2, 3, 4, 6, and 8 | — |
| Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale | 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 |
Countries
United States
Participant flow
Pre-assignment details
After screening, eligible subjects were randomized to treatment in the double-blind phase. After completing the double-blind phase or discontinuing due to specific weight loss criteria, eligible subjects could enter an open-label extension phase.
Participants by arm
| Arm | Count |
|---|---|
| DB MA-CS 550 mg/Day MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase | 4 |
| DB Placebo Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase | 1 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-blind Phase | Adverse Event | 1 | 0 | 0 |
| Double-blind Phase | Non-compliance | 2 | 0 | 0 |
| Double-blind Phase | Study Discontinued | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | DB MA-CS 550 mg/Day | DB Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 4 | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 2 / 4 | 0 / 1 | 0 / 0 |
Outcome results
Primary
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
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.
Time frame: 8 weeks
Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.
Secondary
Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale
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
Time frame: Baseline, Weeks 1, 2, 3, 4, 6 and 8
Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.
Secondary
Change in Weight Over the Course of the 8-week Double-blind Phase
Time frame: Baseline, Week 1, 2, 3, 4, 6, and 8
Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.
Secondary
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
Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.