<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03283488</url>
  </required_header>
  <id_info>
    <org_study_id>Mirtazapine_Cachexia</org_study_id>
    <nct_id>NCT03283488</nct_id>
  </id_info>
  <brief_title>Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.</brief_title>
  <official_title>Randomized, Double-blind Clinical Trial of the Use of Mirtazapine Versus Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the&#xD;
      patient's quality of life, but is also associated with a significant reduction in survival.&#xD;
      Despite its clinical importance, it remains a widely underestimated and untreated condition.&#xD;
      Considering the scarcity of pharmacological measures, it is necessary to invest in studies&#xD;
      that may contribute to the rational and effective treatment of this clinical condition.&#xD;
      Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few&#xD;
      adverse effects and with well-known orexigenic action in clinical practice.The objective of&#xD;
      this study is to evaluate the effect of mirtazapine as a pharmacological measure in the&#xD;
      management of cancer-related anorexia-cachexia in patients in palliative care. A randomized,&#xD;
      double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative&#xD;
      care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and&#xD;
      will be evaluated longitudinally for a period of 8 weeks. The primary endpoint will be to&#xD;
      assess the effect of mirtazapine on anorexia and weight gain and secondary outcomes will be&#xD;
      to assess the tolerability and safety of mirtazapine and the effect of mirtazapine on body&#xD;
      composition, quality of life, and functional capacity of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the&#xD;
      patient's quality of life, but is also associated with a significant reduction in survival.&#xD;
      Unintentional weight loss can predict a poor prognosis in cancer patients which is most&#xD;
      likely due to decreased doses of treatment. Despite its clinical importance, it remains a&#xD;
      widely underestimated and untreated condition. Considering the scarcity of pharmacological&#xD;
      measures, it is necessary to invest in studies that may contribute to the rational and&#xD;
      effective treatment of this clinical condition. Mirtazapine has a special therapeutic&#xD;
      potential because it is a well-tolerated drug with few adverse effects and with well-known&#xD;
      orexigenic action in clinical practice. It has been shown to have side effects of increased&#xD;
      appetite and weight gain in cancer subjects with depression and nausea, as well as in&#xD;
      non-depressed cancer patients, but there are not, as yet, randomized controlled trials&#xD;
      showing its effect on cancer-associated anorexia-cachexia. The objective of this study is to&#xD;
      evaluate the effect of mirtazapine as a pharmacological measure in the management of&#xD;
      cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind&#xD;
      clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be&#xD;
      conducted. Patients will be randomized to receive mirtazapine or megestrol and will be&#xD;
      evaluated longitudinally for a period of 8 weeks. After the initial evaluation and&#xD;
      randomization, patients will be reassessed after 4 and 8 weeks at an outpatient clinic where&#xD;
      they will be evaluated for the following variables: (1) General and demographic&#xD;
      characteristics; (2) Usual food intake; (3) Anthropometric evaluation; (4) Presence and&#xD;
      degree of symptoms using the Edmonton Symptom Assessment System; (4) Status performance using&#xD;
      the Karnofsky performance status; (5) Quality of life using the QLQ-C30 Questionnaire; (6)&#xD;
      Depression using the Hospital Anxiety and Depression Scale; (7) Prognosis using the&#xD;
      Palliative Prognostic Score; (8) Evaluation of functional capacity using hand grip strength&#xD;
      and gait speed; (9) Body composition using electrical bioimpedance and dual energy x-ray&#xD;
      absorptiometry; (10) Physical Activity Behaviour using a tri-axial accelerometer. Patients&#xD;
      will also be contacted via telephone calls at weeks 1, 2, 3, 5 and 6 for information&#xD;
      regarding adverse events and drug compliance. The questioning about the occurrence of adverse&#xD;
      events will also be performed at the outpatient clinic. Self-report of ingestion of tablets&#xD;
      and counting of tablets on return of packages at the end of the study will be used to&#xD;
      determine patient compliance. It is expect that use of mirtazapine can bring benefits&#xD;
      increasing appetite and the body weight in cancer patientes in palliative care compared to&#xD;
      the use of megestrol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">February 2, 2022</completion_date>
  <primary_completion_date type="Actual">February 2, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in appetite</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by Edmonton Symptom Assessment Scale. This evaluation will be collected at baseline and after 8 weeks of follow-up. Changes in appetite will be divided into 3 categories according to the following definitions: appetite improvement will be a decrease ≥ 2 points in Edmonton Symptom Assessment Scale, maintenance of appetite as an improvement or worsening of 1 point and worsening of appetite as deterioration ≥ 2 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by body weight. This evaluation will be collected at baseline and after 8 weeks of follow-up. The weight changes will be divided into 3 categories according to the following definitions: weight improvement will be a gain ≥ 1 kg, weight maintenance will be a loss &lt; 500g or a gain &lt; 1kg and weight loss will be a loss ≥ 500g.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body lean and fat mass</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by body bioelectrical impedance and dual energy x-ray absorptiometry. They will be performed at baseline and after 8 weeks of follow-up. The body bioelectrical impedance will be performed using the ImpediMed DF50 mono-frequency system (ImpediMed Limited, Australia). The dual energy x-ray absorptiometry will be performed on the measuring table using the equipment-specific software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>8 weeks</time_frame>
    <description>The European Organization for Research and Treatment of Cancer (EORTC) instrument QLQ-C30 Questionnaire will be used to assess quality of life at baseline and after 8 weeks of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of muscle strength</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by hand grip strenght measured by the use of a manual hydraulic dynamometer (Saehan, model SH 5.001, Koreia). It will be performed at baseline and after 8 weeks of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of gait speed</measure>
    <time_frame>8 weeks</time_frame>
    <description>The gait speed will be measured at 4 meters on usual speed. It will be performed at baseline and after 8 weeks of follow-up. The results will be expressed in m/s.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity behaviour</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by a tri-axial accelerometer to measure profile of spontaneous physical activity. It will be performed at first week and the last week of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-related Adverse Events</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by contact via telephone calls at weeks 1, 2, 3, 5 and 6 for information regarding treatment-related adverse events. The questioning about the occurrence of treatment-related adverse events will also be performed at the outpatient clinic at baseline and weeks 4 and 8 during the follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Cachexia; Cancer</condition>
  <condition>Anorexia</condition>
  <arm_group>
    <arm_group_label>Mirtazapine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Megestrol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirtazapine</intervention_name>
    <description>Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.</description>
    <arm_group_label>Mirtazapine</arm_group_label>
    <other_name>Remeron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Megestrol</intervention_name>
    <description>Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.</description>
    <arm_group_label>Megestrol</arm_group_label>
    <other_name>megestrol acetate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥ 50 years.&#xD;
&#xD;
          -  Patients with confirmed diagnosis of cancer by histopathological examination,&#xD;
             including those not yet submitted to any therapy because they are in the therapeutic&#xD;
             definition phase and those whose therapies have already been suspended because they&#xD;
             are ineffective.&#xD;
&#xD;
          -  Patients with cancer progression, with either local or distant metastases, documented&#xD;
             by radiological or histopathological methods.&#xD;
&#xD;
          -  Patients complaining of anorexia graded by the patient as ≥ 5 by the Edmonton Sympton&#xD;
             Assessement Scale.&#xD;
&#xD;
          -  Patients with weight loss ≥ 2% in the last 2 months or weight loss ≥ 5% in the last 6&#xD;
             months, referred by the patient or documented in electronic medical records, compared&#xD;
             to the stable weight before diagnosis.&#xD;
&#xD;
          -  Patients with a life expectancy of ≥ 2 months by the Palliative Prognostic Score.&#xD;
&#xD;
          -  Patients with performance status greater than or equal to 60% using the Karnofsky&#xD;
             Performance Status scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with depression or using antidepressant therapy with a score ≥ 12&#xD;
             in the depression items of the Hospital Anxiety and Depression Scale.&#xD;
&#xD;
          -  Patients with unstable doses of corticosteroids.&#xD;
&#xD;
          -  Patients with moderate renal and/or hepatic dysfunction (total bilirubin ≥ 1.5x the&#xD;
             upper limit of normal, AST and ALT ≥ 5x upper limit of normal or creatinine ≥1.5x&#xD;
             upper limit of normal).&#xD;
&#xD;
          -  Patients with Central Nervous System metastases.&#xD;
&#xD;
          -  Patients with inability to take oral medications.&#xD;
&#xD;
          -  Patients with mechanical obstruction of the gastrointestinal tract.&#xD;
&#xD;
          -  Patients with clinically bulky ascites and generalized edema.&#xD;
&#xD;
          -  Patients with reports of allergy to the medications studied.&#xD;
&#xD;
          -  Patients with hypothyroidism with TSH levels greater than or equal to 5 μU/mL and free&#xD;
             T4 less than 0.7 ng/dL.&#xD;
&#xD;
          -  Patients with uncorrected hydroelectrolytic disturbances, with altered serum sodium,&#xD;
             potassium and/ or ionic calcium.&#xD;
&#xD;
          -  Patients with persistent and uncontrolled nausea and/or vomiting associated with&#xD;
             gastrointestinal tract neoplasia and/or chemotherapeutic or radiotherapeutic&#xD;
             treatment.&#xD;
&#xD;
          -  Patients with pacemakers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nereida KC Lima, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinics Hospital, Ribeirão Preto Medical School, University of São Paulo</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14048900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://fmrp.usp.br</url>
    <description>webpage of the Ribeirão Preto Medical School</description>
  </link>
  <reference>
    <citation>Riechelmann RP, Burman D, Tannock IF, Rodin G, Zimmermann C. Phase II trial of mirtazapine for cancer-related cachexia and anorexia. Am J Hosp Palliat Care. 2010 Mar;27(2):106-10. doi: 10.1177/1049909109345685. Epub 2009 Sep 23.</citation>
    <PMID>19776373</PMID>
  </reference>
  <reference>
    <citation>Theobald DE, Kirsh KL, Holtsclaw E, Donaghy K, Passik SD. An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms. J Pain Symptom Manage. 2002 May;23(5):442-7. doi: 10.1016/s0885-3924(02)00381-0.</citation>
    <PMID>12007762</PMID>
  </reference>
  <reference>
    <citation>Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.</citation>
    <PMID>12937858</PMID>
  </reference>
  <reference>
    <citation>Wen HS, Li X, Cao YZ, Zhang CC, Yang F, Shi YM, Peng LM. Clinical studies on the treatment of cancer cachexia with megestrol acetate plus thalidomide. Chemotherapy. 2012;58(6):461-7. doi: 10.1159/000346446. Epub 2013 Feb 7.</citation>
    <PMID>23406994</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Nereida Kilza da Costa Lima</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>anorexia</keyword>
  <keyword>cachexia</keyword>
  <keyword>mirtazapine</keyword>
  <keyword>megestrol</keyword>
  <keyword>palliative care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wasting Syndrome</mesh_term>
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Megestrol</mesh_term>
    <mesh_term>Megestrol Acetate</mesh_term>
    <mesh_term>Mirtazapine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD to be made available after the end of the study protocol.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>after the publication of the results of study.</ipd_time_frame>
    <ipd_access_criteria>researchers after the review and approval of protocol by the principal investigator</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283488
org study id: Mirtazapine_Cachexia
nct id: NCT03283488
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the
      patient's quality of life, but is also associated with a significant reduction in survival.
      Despite its clinical importance, it remains a widely underestimated and untreated condition.
      Considering the scarcity of pharmacological measures, it is necessary to invest in studies
      that may contribute to the rational and effective treatment of this clinical condition.
      Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few
      adverse effects and with well-known orexigenic action in clinical practice.The objective of
      this study is to evaluate the effect of mirtazapine as a pharmacological measure in the
      management of cancer-related anorexia-cachexia in patients in palliative care. A randomized,
      double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative
      care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and
      will be evaluated longitudinally for a period of 8 weeks. The primary endpoint will be to
      assess the effect of mirtazapine on anorexia and weight gain and secondary outcomes will be
      to assess the tolerability and safety of mirtazapine and the effect of mirtazapine on body
      composition, quality of life, and functional capacity of patients.
Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the
      patient's quality of life, but is also associated with a significant reduction in survival.
      Unintentional weight loss can predict a poor prognosis in cancer patients which is most
      likely due to decreased doses of treatment. Despite its clinical importance, it remains a
      widely underestimated and untreated condition. Considering the scarcity of pharmacological
      measures, it is necessary to invest in studies that may contribute to the rational and
      effective treatment of this clinical condition. Mirtazapine has a special therapeutic
      potential because it is a well-tolerated drug with few adverse effects and with well-known
      orexigenic action in clinical practice. It has been shown to have side effects of increased
      appetite and weight gain in cancer subjects with depression and nausea, as well as in
      non-depressed cancer patients, but there are not, as yet, randomized controlled trials
      showing its effect on cancer-associated anorexia-cachexia. The objective of this study is to
      evaluate the effect of mirtazapine as a pharmacological measure in the management of
      cancer-related anorexia-cachexia in patients in palliative care. A randomized, double-blind
      clinical trial involving 52 cancer patients with anorexia-cachexia in palliative care will be
      conducted. Patients will be randomized to receive mirtazapine or megestrol and will be
      evaluated longitudinally for a period of 8 weeks. After the initial evaluation and
      randomization, patients will be reassessed after 4 and 8 weeks at an outpatient clinic where
      they will be evaluated for the following variables: (1) General and demographic
      characteristics; (2) Usual food intake; (3) Anthropometric evaluation; (4) Presence and
      degree of symptoms using the Edmonton Symptom Assessment System; (4) Status performance using
      the Karnofsky performance status; (5) Quality of life using the QLQ-C30 Questionnaire; (6)
      Depression using the Hospital Anxiety and Depression Scale; (7) Prognosis using the
      Palliative Prognostic Score; (8) Evaluation of functional capacity using hand grip strength
      and gait speed; (9) Body composition using electrical bioimpedance and dual energy x-ray
      absorptiometry; (10) Physical Activity Behaviour using a tri-axial accelerometer. Patients
      will also be contacted via telephone calls at weeks 1, 2, 3, 5 and 6 for information
      regarding adverse events and drug compliance. The questioning about the occurrence of adverse
      events will also be performed at the outpatient clinic. Self-report of ingestion of tablets
      and counting of tablets on return of packages at the end of the study will be used to
      determine patient compliance. It is expect that use of mirtazapine can bring benefits
      increasing appetite and the body weight in cancer patientes in palliative care compared to
      the use of megestrol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in appetite
time frame: 8 weeks
description: Assessed by Edmonton Symptom Assessment Scale. This evaluation will be collected at baseline and after 8 weeks of follow-up. Changes in appetite will be divided into 3 categories according to the following definitions: appetite improvement will be a decrease ≥ 2 points in Edmonton Symptom Assessment Scale, maintenance of appetite as an improvement or worsening of 1 point and worsening of appetite as deterioration ≥ 2 points.
measure: Change in body weight
time frame: 8 weeks
description: Assessed by body weight. This evaluation will be collected at baseline and after 8 weeks of follow-up. The weight changes will be divided into 3 categories according to the following definitions: weight improvement will be a gain ≥ 1 kg, weight maintenance will be a loss < 500g or a gain < 1kg and weight loss will be a loss ≥ 500g.
measure: Change in body lean and fat mass
time frame: 8 weeks
description: Assessed by body bioelectrical impedance and dual energy x-ray absorptiometry. They will be performed at baseline and after 8 weeks of follow-up. The body bioelectrical impedance will be performed using the ImpediMed DF50 mono-frequency system (ImpediMed Limited, Australia). The dual energy x-ray absorptiometry will be performed on the measuring table using the equipment-specific software.
measure: Change in Quality of life
time frame: 8 weeks
description: The European Organization for Research and Treatment of Cancer (EORTC) instrument QLQ-C30 Questionnaire will be used to assess quality of life at baseline and after 8 weeks of follow-up.
measure: Assessment of muscle strength
time frame: 8 weeks
description: Assessed by hand grip strenght measured by the use of a manual hydraulic dynamometer (Saehan, model SH 5.001, Koreia). It will be performed at baseline and after 8 weeks of follow-up.
measure: Assessment of gait speed
time frame: 8 weeks
description: The gait speed will be measured at 4 meters on usual speed. It will be performed at baseline and after 8 weeks of follow-up. The results will be expressed in m/s.
measure: Physical Activity behaviour
time frame: 8 weeks
description: Assessed by a tri-axial accelerometer to measure profile of spontaneous physical activity. It will be performed at first week and the last week of follow-up.
measure: Incidence of treatment-related Adverse Events
time frame: 8 weeks
description: Assessed by contact via telephone calls at weeks 1, 2, 3, 5 and 6 for information regarding treatment-related adverse events. The questioning about the occurrence of treatment-related adverse events will also be performed at the outpatient clinic at baseline and weeks 4 and 8 during the follow-up.
arm group label: Mirtazapine
arm group type: Experimental
description: Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
arm group label: Megestrol
arm group type: Active Comparator
description: Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
intervention type: Drug
intervention name: Mirtazapine
description: Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
arm group label: Mirtazapine
other name: Remeron
intervention type: Drug
intervention name: Megestrol
description: Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
arm group label: Megestrol
other name: megestrol acetate
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Nereida KC Lima, MD, PhD
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
url: http://fmrp.usp.br
description: webpage of the Ribeirão Preto Medical School
citation: Riechelmann RP, Burman D, Tannock IF, Rodin G, Zimmermann C. Phase II trial of mirtazapine for cancer-related cachexia and anorexia. Am J Hosp Palliat Care. 2010 Mar;27(2):106-10. doi: 10.1177/1049909109345685. Epub 2009 Sep 23.
PMID: 19776373
citation: Theobald DE, Kirsh KL, Holtsclaw E, Donaghy K, Passik SD. An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms. J Pain Symptom Manage. 2002 May;23(5):442-7. doi: 10.1016/s0885-3924(02)00381-0.
PMID: 12007762
citation: Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.
PMID: 12937858
citation: Wen HS, Li X, Cao YZ, Zhang CC, Yang F, Shi YM, Peng LM. Clinical studies on the treatment of cancer cachexia with megestrol acetate plus thalidomide. Chemotherapy. 2012;58(6):461-7. doi: 10.1159/000346446. Epub 2013 Feb 7.
PMID: 23406994
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Nereida Kilza da Costa Lima
investigator title: Assistant Professor
mesh term: Wasting Syndrome
mesh term: Anorexia
mesh term: Cachexia
mesh term: Megestrol
mesh term: Megestrol Acetate
mesh term: Mirtazapine
sharing ipd: Yes
ipd description: IPD to be made available after the end of the study protocol.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: after the publication of the results of study.
ipd access criteria: researchers after the review and approval of protocol by the principal investigator