AnorexiaPhase 3NCT00637806

Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

A Phase 3 study testing Megestrol acetate concentrated suspension 110 mg/mL and Megestrol acetate concentrated suspension 60 mg/mL in people with Anorexia and Cachexia, run by Par Pharmaceutical, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anorexia, Cachexia, Weight Loss
What is being tested?: Megestrol acetate concentrated suspension 110 mg/mL and Megestrol acetate concentrated suspension 60 mg/mL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 4 sitesUnited States
Study dates: Jun 2006to Sep 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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)

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Summit Oncology Associates, Inc.
Akron, Ohio, 44304
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801
Four Seasons Hospice and Paliative Care
Flat Rock, North Carolina, 28731
Wake Forest University
High Point, North Carolina, 27262

Other trials in United States

About this study

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

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Conditions: Anorexia, Cachexia, Weight Loss
Being tested: Megestrol acetate concentrated suspension 110 mg/mL, Megestrol acetate concentrated suspension 60 mg/mL, Placebo
Keywords: Megestrol acetate, Anorexia, Cachexia, Cancer, Unintended weight loss, Body weight, Appetite, Megace ES
Medical subject headings: Anorexia, Cachexia, Weight Loss, Neoplasms, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Megestrol acetate concentrated suspension 110 mg/mLDrug
Also called Megace ES
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
Megestrol acetate concentrated suspension 60 mg/mLDrug
Also called Megace ES
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
PlaceboDrug
Placebo oral suspension, 5 mL once daily

Study groups in NCT00637806
Study group	Role	What they receive
1	Active comparator	Megestrol acetate concentrated suspension 110 mg/mL Receives: Drug: Megestrol acetate concentrated suspension 110 mg/mL
2	Active comparator	Megestrol acetate concentrated suspension 60 mg/mL Receives: Drug: Megestrol acetate concentrated suspension 60 mg/mL
3	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (3)

Change in Weight Over the Course of the 8-week Double-blind Phase
Measured: 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
Measured: Baseline, Week 4 and Week 8
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
Measured: Baseline, Weeks 1, 2, 3, 4, 6 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Sep 2006

First posted18 Mar 2008 (estimated)
Study startJun 2006
Primary completionSep 2006
Study completionSep 2006

Why it stopped: Difficulty finding the required patient population

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnorexiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00637806
Sponsor's protocol ID: 100.2.C.005 TRANSFERRED
Status last verified: Mar 2016
First submitted: 11 Mar 2008
Last updated: 2 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)

All Anorexia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00637806
Acronym / sponsor ID: 100.2.C.005 TRANSFERRED
Conditions: Anorexia, Cachexia, Weight Loss
Keywords: Megestrol acetate, Anorexia, Cachexia, Cancer, Unintended weight loss, Body weight, Appetite, Megace ES
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty finding the required patient population
Enrolment: 4 participants (actual)
Lead sponsor: Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
Collaborators: PRA Health Sciences
Study start: Jun 2006
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 18 Mar 2008 (estimated)
Results: Posted 2 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: Megestrol acetate concentrated suspension 110 mg/mLMegestrol acetate concentrated suspension 110 mg/mL
2	Active comparator	Drug: Megestrol acetate concentrated suspension 60 mg/mLMegestrol acetate concentrated suspension 60 mg/mL
3	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Megestrol acetate concentrated suspension 110 mg/mLAlso: Megace ESMegestrol 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	Drug	1
Megestrol acetate concentrated suspension 60 mg/mLAlso: Megace ESMegestrol 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	Drug	2
PlaceboPlacebo oral suspension, 5 mL once daily	Drug	3

Primary outcome

Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
Time frame: 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.

3 secondary outcomes

Change in Weight Over the Course of the 8-week Double-blind Phase
Time frame: 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
Time frame: Baseline, Week 4 and Week 8
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

Results and safety

Results posted to the registry on 2 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DB MA-CS 550 mg/Day	2	0
DB MA-CS 300 mg/Day	0	0
DB Placebo	2	1
OL MA-CS 550 mg/Day	0	0

Primary outcome: Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase

Time frame: 8 weeks

Population analysed: Results not analyzed due to early termination of the study

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 98 days (from informed consent through 7 days following the last dose of study drug or up until the last protocol-specified study visit, whichever occurred later). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DB MA-CS 550 mg/Day	0 of 2 (0%)	1 of 2 (50%)	Not reported
DB MA-CS 300 mg/Day	0 of 0	0 of 0	Not reported
DB Placebo	1 of 2 (50%)	2 of 2 (100%)	Not reported
OL MA-CS 550 mg/Day	1 of 1 (100%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anorexia

Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lynn D Kramer, MD study chair

Par Pharmaceutical, Inc.

Janet Bull, MD principal investigator

Four Seasons Hospice and Paliative Care

Veena Charu, MD principal investigator

Pacific Cancer Medical Center, Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00637806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.