AnorexiaPhase 3NCT00637728
Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients
A Phase 3 study testing Megestrol acetate concentrated suspension 110 mg/mL in people with Anorexia and Cachexia, run by Par Pharmaceutical, Inc. at 3 sites in United States.
Trial 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 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 3 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
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Western Maryland Health System
Cumberland, Maryland, 21502
Innovative Medical Research of South Florida, Inc
Miami, Florida, 33179
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, 29464
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 Lung or Pancreatic Cancer
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
- Conditions
- Anorexia, Cachexia, Weight Loss
- Being tested
- Megestrol acetate concentrated suspension 110 mg/mL, Placebo
- Keywords
- Megestrol acetate, Anorexia, Cachexia, Lung cancer, Pancreatic cancer, Unintended weight loss, Body weight, Appetite, Megace ES
- Medical subject headings
- Anorexia, Cachexia, Weight Loss, Lung Neoplasms, Pancreatic 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
PlaceboDrug
Placebo oral suspension, 5 mL once daily
| 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 | Placebo comparator | Placebo suspension 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)
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 Weight Over the Course of the 8-week Double-blind Phase
Measured: 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
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.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Lynn D Kramer, MD, Study chair, Par Pharmaceutical, Inc.John N Mehanna, MD, Principal investigator, Western Maryland Health SystemM.Daud Nawabi, MD, Principal investigator, Lowcountry Hematology & Oncology, PAMarc A Saltzman, MD, Principal investigator, Innovative Medical Research of South Florida, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637728
- Sponsor's protocol ID
- 100.2.C.006 TRANSFERRED
- Status last verified
- May 2016
- First submitted
- 11 Mar 2008
- Last updated
- 23 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 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 Lung or Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00637728
- Acronym / sponsor ID
- 100.2.C.006 TRANSFERRED
- Conditions
- Anorexia, Cachexia, Weight Loss
- Keywords
- Megestrol acetate, Anorexia, Cachexia, Lung cancer, Pancreatic cancer, Unintended weight loss, Body weight, Appetite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty finding the required patient population
- Enrolment
- 5 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 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Megestrol acetate concentrated suspension 110 mg/mLMegestrol acetate concentrated suspension 110 mg/mL |
| 2 | Placebo comparator | Drug: PlaceboPlacebo suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
| PlaceboPlacebo oral suspension, 5 mL once daily | Drug | 2 |
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
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 Weight Over the Course of the 8-week Double-blind Phase
Time frame: 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
Time frame: Baseline, Weeks 1, 2, 3, 4, 6 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John N Mehanna, MD principal investigator
Western Maryland Health System
M.Daud Nawabi, MD principal investigator
Lowcountry Hematology & Oncology, PA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol acetate concentrated suspension 110 mg/mL in people with Anorexia and Cachexia, run by Par Pharmaceutical, Inc. at 3 sites in United States.
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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 29 Feb 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?
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 23 Jun 2016.