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

Primary Purpose

Anorexia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Megestrol Acetate
Mirtazapine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm A (megestrol alone)

    Arm B (megestrol plus mirtazapine)

    Arm Description

    Megestrol acetate 800 mg PO daily x 8 weeks

    Megestrol 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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Weight change (in lbs)
    Change over time as well as the difference between groups for weight (in lbs) will be analyzed.
    Appetite stimulation
    Assessed using Simplified Nutritional Appetite Questionnaire (SNAQ). The change over time as well as the difference between groups will be analyzed.
    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.
    Mood assessments
    Measured using CES-D. The Change over time as well as the difference between groups will be analyzed.
    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).

    Full Information

    First Posted
    December 20, 2011
    Last Updated
    January 31, 2014
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01501396
    Brief Title
    Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite
    Official Title
    Treatment of Cancer Anorexia-cachexia Syndrome (CACS) With Mirtazapine and Megestrol Acetate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A (megestrol alone)
    Arm Type
    Experimental
    Arm Description
    Megestrol acetate 800 mg PO daily x 8 weeks
    Arm Title
    Arm B (megestrol plus mirtazapine)
    Arm Type
    Experimental
    Arm Description
    Megestrol 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
    Intervention Type
    Drug
    Intervention Name(s)
    Megestrol Acetate
    Other Intervention Name(s)
    BDH 1298, Maygace, Megace, Megestil, Niagestin, Pallace
    Intervention Type
    Drug
    Intervention Name(s)
    Mirtazapine
    Other Intervention Name(s)
    Remeron
    Primary Outcome Measure Information:
    Title
    Response rates for weight gain
    Description
    Determine the rates of >= 5% weight gain in the treatment groups. Compare the difference of the response rate between the 2 groups.
    Time Frame
    Baseline to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability of MA alone and MA + MRZ
    Description
    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
    Time Frame
    Baseline to 12 weeks (30 days after end of study)
    Title
    Weight change (in lbs)
    Description
    Change over time as well as the difference between groups for weight (in lbs) will be analyzed.
    Time Frame
    Baseline to 8 weeks
    Title
    Appetite stimulation
    Description
    Assessed using Simplified Nutritional Appetite Questionnaire (SNAQ). The change over time as well as the difference between groups will be analyzed.
    Time Frame
    Baseline to 8 weeks
    Title
    Quality of life
    Description
    Assessed using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The Change over time as well as the difference between groups will be analyzed.
    Time Frame
    Baseline to 8 weeks
    Title
    Mood assessments
    Description
    Measured using CES-D. The Change over time as well as the difference between groups will be analyzed.
    Time Frame
    Baseline to 8 weeks
    Title
    Evaluation of biochemical markers
    Description
    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).
    Time Frame
    Baseline to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saiama Waqar, M.D.
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.siteman.wustl.edu
    Description
    Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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