<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/NCT03263520</url>
  </required_header>
  <id_info>
    <org_study_id>HEG03</org_study_id>
    <nct_id>NCT03263520</nct_id>
  </id_info>
  <brief_title>Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer</brief_title>
  <official_title>Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Erasto Gaertner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Erasto Gaertner</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Compare the use of nandrolone associated with corticosteroid for the treatment of&#xD;
      cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors&#xD;
      in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Compare muscle mass values obtained before and after the use of anabolic steroids upon&#xD;
           assessment by bioelectrical impedance analysis (BIA).&#xD;
&#xD;
        -  Compare the anabolic effect on quality of life (QLo) of the patient before and after the&#xD;
           use of anabolic steroids.&#xD;
&#xD;
        -  Compare data from laboratory tests such as complete blood count, albumin, C reactive&#xD;
           protein and transferrin with drug intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Randomization will be made at the time of study enrollment by , where patients randomly selected as even number will be included in group 1 and those selected as odd number in group 2Group 1 (G1): the patient will receive an application of anabolic nandrolone decanoate at a dose of 50 mg (males) and 25 mg (females), intra-muscular form, in the first and fifteenth days. In addition to the anabolic steroid, the patient will use corticosteroids (dexamethasone) at home at a dose of 4 mg daily for both sexes.&#xD;
Group 2 (G2): The patient will use corticosteroids (dexamethasone) at a dose of 4 mg daily.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor and investigator does not have contact with the patient or care provider at the moment of randomization and the study purpose. The investigator just apply the bioelectrical impedance analysis and helps the patient about doubts on the Quality of Life questionnaire of EORTC ( QLQ-C30)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients</measure>
    <time_frame>After 30 days, the values will be compared to those obtained on the first consultant.</time_frame>
    <description>Evaluate the BMI ( body mass index)- the weight in kilograms and the height in centimeters and BMI in Kg/ m2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients by bioimpedance analysis ( BIA)</measure>
    <time_frame>After 30 days, the values will be compared to those obtained on the first consultant.</time_frame>
    <description>Evaluate the BIA (biometrical impedance analysis)trough the reactance and resistance in ohms and the phase angle in degree.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ompare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients trough quality of life assessment</measure>
    <time_frame>After 30 days, the values will be compared to those obtained on the first consultant.</time_frame>
    <description>Evaluate quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnare Core 30 ( QLQ-C30), version 3.0 . The values are expressed as a percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare data from laboratory tests: complete blood count, albumin, C reactive protein and transferrin with drug intervention.</measure>
    <time_frame>After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.</time_frame>
    <description>The complete blood count will be expressed in millions by cubic milimiter( millions/mm3) , albumin in grams per deciliter (g/dL), C reactive protein in milligrams per deciliter (mg/dL), transferrin in milligrams per deciliter (mg/dL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cachexia; Cancer</condition>
  <arm_group>
    <arm_group_label>Group 1: nandrolone and corticosteroid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patient will receive an application of anabolic nandrolone decanoate at a dose of 50 mg (males) and 25 mg (females), intra-muscular form, in the first and fifteenth days. In addition to the anabolic steroid, the patient will use corticosteroids (dexamethasone) at home at a dose of 4 mg daily by mouth on the morning for both sexes for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: corticosteroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nandrolone Decanoate</intervention_name>
    <description>Drug administration</description>
    <arm_group_label>Group 1: nandrolone and corticosteroid</arm_group_label>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Drug administration</description>
    <arm_group_label>Group 2: corticosteroid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer patients above 18 years old.&#xD;
&#xD;
          -  Patients with tumors in the high gastro-intestinal, hepatobiliary and pancreatic&#xD;
             tracts in palliation.&#xD;
&#xD;
          -  Patients able to undergo BIA.&#xD;
&#xD;
          -  Malnourished patients as per the subjective global assessment produced by the patient&#xD;
             (ASG-PPP) and whose score is greater than nine.&#xD;
&#xD;
          -  Patients who agree to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with malignant tumors of other metachronous or synchronous location except&#xD;
             nonmelanoma skin tumor&#xD;
&#xD;
          -  Patients with chronic renal failure.&#xD;
&#xD;
          -  Patients on diuretics, recent or chronic.&#xD;
&#xD;
          -  Patients on appetite stimulants and anabolic agents.&#xD;
&#xD;
          -  Patients using pacemakers, which can interfere with the results of BIA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vinicius B Preti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Erasto Gaertner</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>81520060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nandrolone Decanoate</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Nandrolone</mesh_term>
    <mesh_term>Nandrolone phenpropionate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03263520
org study id: HEG03
nct id: NCT03263520
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Compare the use of nandrolone associated with corticosteroid for the treatment of
      cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors
      in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.
-  Compare muscle mass values obtained before and after the use of anabolic steroids upon
           assessment by bioelectrical impedance analysis (BIA).

        -  Compare the anabolic effect on quality of life (QLo) of the patient before and after the
           use of anabolic steroids.

        -  Compare data from laboratory tests such as complete blood count, albumin, C reactive
           protein and transferrin with drug intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization will be made at the time of study enrollment by , where patients randomly selected as even number will be included in group 1 and those selected as odd number in group 2Group 1 (G1): the patient will receive an application of anabolic nandrolone decanoate at a dose of 50 mg (males) and 25 mg (females), intra-muscular form, in the first and fifteenth days. In addition to the anabolic steroid, the patient will use corticosteroids (dexamethasone) at home at a dose of 4 mg daily for both sexes.
Group 2 (G2): The patient will use corticosteroids (dexamethasone) at a dose of 4 mg daily.
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: The outcomes assessor and investigator does not have contact with the patient or care provider at the moment of randomization and the study purpose. The investigator just apply the bioelectrical impedance analysis and helps the patient about doubts on the Quality of Life questionnaire of EORTC ( QLQ-C30)
measure: Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients
time frame: After 30 days, the values will be compared to those obtained on the first consultant.
description: Evaluate the BMI ( body mass index)- the weight in kilograms and the height in centimeters and BMI in Kg/ m2.
measure: Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients by bioimpedance analysis ( BIA)
time frame: After 30 days, the values will be compared to those obtained on the first consultant.
description: Evaluate the BIA (biometrical impedance analysis)trough the reactance and resistance in ohms and the phase angle in degree.
measure: ompare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients trough quality of life assessment
time frame: After 30 days, the values will be compared to those obtained on the first consultant.
description: Evaluate quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnare Core 30 ( QLQ-C30), version 3.0 . The values are expressed as a percentage
measure: Compare data from laboratory tests: complete blood count, albumin, C reactive protein and transferrin with drug intervention.
time frame: After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.
description: The complete blood count will be expressed in millions by cubic milimiter( millions/mm3) , albumin in grams per deciliter (g/dL), C reactive protein in milligrams per deciliter (mg/dL), transferrin in milligrams per deciliter (mg/dL)
arm group label: Group 1: nandrolone and corticosteroid
arm group type: Experimental
description: the patient will receive an application of anabolic nandrolone decanoate at a dose of 50 mg (males) and 25 mg (females), intra-muscular form, in the first and fifteenth days. In addition to the anabolic steroid, the patient will use corticosteroids (dexamethasone) at home at a dose of 4 mg daily by mouth on the morning for both sexes for 30 days.
arm group label: Group 2: corticosteroid
arm group type: Active Comparator
description: Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days
intervention type: Drug
intervention name: Nandrolone Decanoate
description: Drug administration
arm group label: Group 1: nandrolone and corticosteroid
other name: Dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Drug administration
arm group label: Group 2: corticosteroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vinicius B Preti, MD
role: Principal Investigator
affiliation: Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Cachexia
mesh term: Nandrolone Decanoate
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Nandrolone
mesh term: Nandrolone phenpropionate
mesh term: BB 1101
sharing ipd: Undecided