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AnorexiaPhase 2NCT01501396

Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite

A Phase 2 study testing Megestrol Acetate and Mirtazapine in people with Anorexia, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This randomized phase II trial studies the safety and efficacy of megestrol acetate given with or without mirtazapine in treating cancer patients with weight loss and loss of appetite. To date, no pharmacologic interventions have been approved by FDA to treat cancer anorexia-cachexia syndrome (CACS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anorexia
What is being tested?
Megestrol Acetate and Mirtazapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2013to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patient must have a histologically or cytologically confirmed solid malignancy
  • Patient must be >=18 years old.
  • Patient must have shown unintentional weight loss of >= 5% in 6 weeks dating back from time of consent or >= 10% in 6 months dating back from time of consent
  • Patient must have a poor appetite (defined as a score of =< 14 on the Simplified Nutritional Appetite Questionnaire (SNAQ)
  • Prior diagnostic or therapeutic surgery is allowed as long as the wound has fully healed, the patient has fully recovered from the procedure, and at least 4 weeks have elapsed from the procedure; for needle or core biopsy, or minimally invasive procedures such as chest tube placement, this 4-week recovery period does not apply, but the patient must have recovered fully from the procedure
  • Concomitant administration of chemotherapy is permitted but not required
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  • Prior radiation therapy is allowed for local symptom palliation prior to the start of treatment as long as at least 2 weeks have elapsed from the procedure and the patient has fully recovered from treatment-related toxicities
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patient must have normal organ and marrow function as defined below:
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patient must be able to understand and willing to sign a written informed consent document

Who cannot join

  • Patient must not be receiving any other investigational agents
  • Patient must not be receiving any tube feeds or parenteral nutrition
  • Patient must not be taking either MA or MRZ within 4 weeks prior to enrolling on the study, prior use of either MA or MRZ more than 4 weeks before enrollment is allowed
  • Patient must not be taking any medication for appetite stimulation within 4 weeks prior to enrolling on the study; prior use of an appetite stimulant more than 4 weeks before enrollment is allowed
  • Patient must not have a known seizure disorder
  • Patient must not have received abdominal radiation within 4 weeks of enrolling on the study; patients who have received abdominal radiation more than 4 weeks prior to enrollment may participate in the study, as long as they have recovered from toxicities of radiation therapy
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  • Patient must not be taking chronic systemic corticosteroids (e.g., prednisone, dexamethasone) within the 4 weeks prior to study entry or while on study (unless as pre-medication for chemotherapy)
  • Patient must not have moderate to severe depression defined as score of >= 20 on the Center for Epidemiologic Studies Depression Scale (CES-D)
  • Patient must not be taking any anti-depressant therapy within the 4 weeks prior to study entry
  • Patient must not be on antipsychotic therapy such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days prior to study; patient may receive prochlorperazine or other phenothiazines as antiemetic therapy
  • Patient must not have a history of phenylketonuria (MRZ compounds contain phenylalanine)
  • Patient must not have active dysphagia or gastrointestinal tract obstruction
  • Patient must not have a previous history of deep venous thrombosis, pulmonary embolism, or thrombophlebitis
  • Patient must not be receiving any other agent to increase appetite or weight such as growth hormone (GH), insulin-like growth factor (IGF-1), growth hormone-releasing hormone, insulin-like growth factor binding protein-3 (IGFBP-3), or cannabinoids within the 6 weeks prior to study entry
  • Patient must not have a body mass index (BMI) > 30
  • Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MA or MRZ
  • Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Mirtazapine can cause non-teratogenic adverse effects on the developing human fetus at the recommended therapeutic dose; for this reason and because MA as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of childbearing potential must have a negative pregnancy test prior to study entry

About this study

Official title: Treatment of Cancer Anorexia-cachexia Syndrome (CACS) With Mirtazapine and Megestrol Acetate

This randomized phase II trial studies the safety and efficacy of megestrol acetate given with or without mirtazapine in treating cancer patients with weight loss and loss of appetite. To date, no pharmacologic interventions have been approved by FDA to treat cancer anorexia-cachexia syndrome (CACS). Megestrol acetate has been shown to increase appetite in cancer patients. Adding mirtazapine may provide a much more effective treatment and help improve quality of life.

Conditions
Anorexia
Being tested
Megestrol Acetate, Mirtazapine
Medical subject headings
Anorexia

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

  • MirtazapineDrug

    Also called Remeron

Study groups in NCT01501396
Study groupRoleWhat they receive
Arm A (megestrol alone)ExperimentalMegestrol acetate 800 mg PO daily x 8 weeks
Receives: Drug: Megestrol Acetate
Arm B (megestrol plus mirtazapine)ExperimentalMegestrol acetate 800 mg PO daily x 8 weeks Mirtazapine 15 mg PO at bedtime x 1 week followed by 30 mg PO at bedtime x 7 weeks
Receives: Drug: Megestrol Acetate; Drug: Mirtazapine

What is being measured

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

  1. Response rates for weight gain

    Determine the rates of >= 5% weight gain in the treatment groups. Compare the difference of the response rate between the 2 groups.

    Measured: Baseline to 8 weeks

Secondary outcomes (6)

  1. Safety and tolerability of MA alone and MA + MRZ

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    Measured: Baseline to 12 weeks (30 days after end of study)

  2. Weight change (in lbs)

    Change over time as well as the difference between groups for weight (in lbs) will be analyzed.

    Measured: Baseline to 8 weeks

  3. Appetite stimulation

    Assessed using Simplified Nutritional Appetite Questionnaire (SNAQ). The change over time as well as the difference between groups will be analyzed.

    Measured: Baseline to 8 weeks

  4. Quality of life

    Assessed using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The Change over time as well as the difference between groups will be analyzed.

    Measured: Baseline to 8 weeks

  5. Mood assessments

    Measured using CES-D. The Change over time as well as the difference between groups will be analyzed.

    Measured: Baseline to 8 weeks

  6. Evaluation of biochemical markers

    Explore the relationship between weight gain and serum markers of nutritional status (prealbumin, transferrin, C-reactive protein, TNF-alpha, and IL-1 and IL-6).

    Measured: Baseline to 8 weeks

Timeline

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

  1. First posted29 Dec 2011 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2015 (estimated)
  4. Study completionSep 2015 (estimated)

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01501396
Sponsor's protocol ID
201202023
Status last verified
Jan 2014
First submitted
20 Dec 2011
Last updated
3 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

    PubMed 36999619

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Megestrol Acetate and Mirtazapine in people with Anorexia, run by Washington University School of Medicine.

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 16 inclusion and 18 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: withdrawn, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Response rates for weight gain (time frame: Baseline to 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 NCT01501396, which also lists 1 linked publication.

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 3 Feb 2014.

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