Treatment of Cancer-associated Anorexia Using Megestrol A... | NCT00637806

NCT00637806

Status Module

Sponsor/Collaborators Module

Name	Class
PRA Health Sciences	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Megestrol acetate concentrated suspension 110 mg/mL	Drug: Megestrol acetate concentrated suspension 110 mg/mL
2	Active Comparator	Megestrol acetate concentrated suspension 60 mg/mL	Drug: Megestrol acetate concentrated suspension 60 mg/mL
3	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Megestrol acetate concentrated suspension 110 mg/mL	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Weight Over the Course of the 8-week Double-blind Phase		Baseline, Week 1, 2, 3, 4, 6, and 8
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

Eligibility Module

Eligibility 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/Locations Module

Overall Officials

Name	Affiliation	Role
Lynn D Kramer, MD	Par Pharmaceutical, Inc.	Study Chair
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.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Cancer Medical Center, Inc.		Anaheim	California	92801	United States
Four Seasons Hospice and Paliative Care

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DB MA-CS 550 mg/Day	Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
FG001	DB MA-CS 300 mg/Day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

All subjects who received at least 1 dose of study medication and who had at least 1 on-therapy safety assessment

Arm/Group Information

ID	Title	Description
BG000	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
BG001	DB MA-CS 300 mg/Day	MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
BG002	DB Placebo	Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0002 BG0010 BG0022 BG0034

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Number

participants

Title

Denominators

Categories

<=18 years

Title	Measurements
	BG0000 BG0020 BG0030

Between 18 and 65 years

Gender

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG0001 BG0020 BG003

Ethnicity (NIH/OMB)

Number

participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG0000 BG0020 BG003

Race (NIH/OMB)

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0020 BG003

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0002 BG0022 BG003

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Results not analyzed due to early termination of the study

Posted

8 weeks

ID	Title	Description
OG000	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
OG001	DB MA-CS 300 mg/Day	MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
OG002	DB Placebo	Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

Change in Weight Over the Course of the 8-week Double-blind Phase

Results not analyzed due to early termination of the study

Posted

Baseline, Week 1, 2, 3, 4, 6, and 8

ID	Title	Description
OG000	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
OG001	DB MA-CS 300 mg/Day	MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
OG002	DB Placebo	Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase

Units	Counts
Participants	OG000

Secondary

Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline

Results not analyzed due to early termination of the study

Posted

Baseline, Week 4 and Week 8

ID	Title	Description
OG000	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
OG001	DB MA-CS 300 mg/Day	MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
OG002	DB Placebo	Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase

Units	Counts
Participants	OG000

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

Results not analyzed due to early termination of the study

Posted

Baseline, Weeks 1, 2, 3, 4, 6 and 8

ID	Title	Description
OG000	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
OG001	DB MA-CS 300 mg/Day	MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
OG002	DB Placebo	Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	2	1	2
EG001	DB MA-CS 300 mg/Day	MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase	0	0	0	0
EG002	DB Placebo	Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase	1	2	2	2
EG003	OL 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 4-week OL extension phase	1	1	1	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Accident at home	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0020 events0 affected2 at risk EG0031 events1 affected1 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0020 events0 affected2 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0020 events0 affected2 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0021 events1 affected2 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Insomnia	Psychiatric disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0021 events1 affected2 at risk EG0031 events1 affected1 at risk
Chest pain	General disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0021 events1 affected2 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0021 events1 affected2 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0021 events1 affected2 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected0 at risk EG0021 events1 affected2 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected0 at risk EG0020 events0 affected2 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected0 at risk EG0020 events0 affected2 at risk EG003
Fatigue	General disorders	MedDRA 8.1	Non-systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected0 at risk EG0020 events0 affected2 at risk EG003

ID	Term
D000855	Anorexia
D002100	Cachexia
D015431	Weight Loss
D009369	Neoplasms
D001835	Body Weight

ID	Term
D019290	Megestrol Acetate

Title	Measurements
	BG0001 BG0020 BG0031

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001836	Body Weight Changes
D013851	Thinness

ID	Term
D008535	Megestrol
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds