AnorexiaPhase 2NCT01200602
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
A Phase 2 study testing megestrol acetate and clinical observation in people with Anorexia and Weight Changes, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Anorexia, Weight Changes
- What is being tested?
- megestrol acetate and clinical observation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jan 2012
- Phase
- Phase 2
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
- ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
- Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only
Who cannot join
- Receiving tube feedings or parenteral nutrition
- Evidence of ascites
- Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
- Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week)
- History of unresectable brain tumor or cancer metastatic to the brain
- History of thromboembolic disease
Show all 11Show fewer
- Insulin-requiring diabetes
- Congestive heart failure and/or uncontrolled hypertension
- Anticoagulation
- Previous history of thrombosis (personal and immediate family)
- Concurrent corticosteroid therapy (except as an antiemetic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.
SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.
- Conditions
- Anorexia, Weight Changes
- Being tested
- megestrol acetate, clinical observation
- Medical subject headings
- Anorexia, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
megestrol acetateDrug
Also called BDH 1298, Maygace, Megace, Megestil
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
clinical observationOther
Also called observation
No treatment is given.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. Receives: Drug: megestrol acetate |
| Arm B | Active comparator | Patients have clinical observation for weight loss and gain for 4 weeks. Receives: Other: clinical observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Maintain Weight or Experience Weight Gain
A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
Measured: 4 weeks
Secondary outcomes (4)
BMI Trends
Measured: 4 weeks
Caloric Intake
Measured: 4 weeks
Weight Maintenance Over Time
Measured: 4 weeks
Toxicity Profile
Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionJan 2012
Why it stopped: The study closed due to slow accrual.
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vilmarie Rodriguez, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200602
- Sponsor's protocol ID
- MC0896
- Other IDs
- NCI-2010-01938, 09-007533, MC0896
- Status last verified
- Oct 2015
- First submitted
- 10 Sep 2010
- Last updated
- 25 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia
- ClinicalTrials.gov ID
- NCT01200602
- Acronym / sponsor ID
- MC0896
- Conditions
- Anorexia, Weight Changes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study closed due to slow accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 24 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.
Detailed description
PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.
SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: megestrol acetatePatients receive oral megestrol acetate 1-2 times daily for 4 weeks. |
| Arm B | Active comparator | Other: clinical observationPatients have clinical observation for weight loss and gain for 4 weeks. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
- ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
- Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only
Key exclusion criteria (11 listed)
- Receiving tube feedings or parenteral nutrition
- Evidence of ascites
- Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
- Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week)
- History of unresectable brain tumor or cancer metastatic to the brain
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 acetateAlso: BDH 1298, Maygace, Megace, MegestilGiven orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day | Drug | Arm A |
| clinical observationAlso: observationNo treatment is given. | Other | Arm B |
Primary outcome
Proportion of Patients Who Maintain Weight or Experience Weight Gain
Time frame: 4 weeks
A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
4 secondary outcomes
BMI Trends
Time frame: 4 weeks
Caloric Intake
Time frame: 4 weeks
Weight Maintenance Over Time
Time frame: 4 weeks
Toxicity Profile
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- 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.
Vilmarie Rodriguez, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing megestrol acetate and clinical observation in people with Anorexia and Weight Changes, run by Mayo Clinic at 1 site 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 3 inclusion and 11 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 May 2013). 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?
Proportion of Patients Who Maintain Weight or Experience Weight Gain (time frame: 4 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 25 Nov 2015.