<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/NCT03759548</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 91570318.5.0000.5149</org_study_id>
    <nct_id>NCT03759548</nct_id>
  </id_info>
  <brief_title>Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer</brief_title>
  <official_title>Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mater Dei Hospital, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Minas Gerais</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>
      Cancer patients undergo many different modalities of treatments. Pharmacological treatment&#xD;
      should be well understood. The nutritional status is not taken into account when calculating&#xD;
      drug's doses and this may have an impact in toxicity and quality of life. The present study&#xD;
      proposes to evaluate the relationship between the calculation of pharmacological treatment's&#xD;
      doses, the toxicity and the impact on quality of life among colorectal and breast cancer's&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer patients undergo various treatment modalities depending on tumor type, location,&#xD;
      disease staging, and overall clinical conditions. Pharmacological treatments and surgeries&#xD;
      are fundamental therapeutic strategies in many cases and are part of the daily routine of&#xD;
      integrated cancer treatment services. The calculation of pharmacological doses often takes&#xD;
      into account the patient's body surface area (BSA) or only weight, without however assessing&#xD;
      their nutritional status as such. The surgical procedure, on the other hand, may expose the&#xD;
      patient to an inflammatory response secondary to the operative trauma that requires immediate&#xD;
      reaction of the diseased organism for an adequate recovery. In this sense, the objective of&#xD;
      the present study is to evaluate the relationship between the calculated medication's doses&#xD;
      and the nutritional status of patients submitted topharmacological treatment with neoadjuvant&#xD;
      or adjuvant intention: patients candidates for surgery. Different instruments will be used&#xD;
      for nutritional assessment, as well as a questionnaire on quality of life, a specific&#xD;
      criterion for evaluation of toxicities, laboratory tests and imaging. Patients will be&#xD;
      observed for 1 year and the data collected will allow the analysis of possible side effects&#xD;
      and the impact on quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact in Quality of Life during pharmacological treatments</measure>
    <time_frame>1 year</time_frame>
    <description>Impact in Quality of Life as assessed by European Organization for Research Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacological treatment-related adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Nutritional Status</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Breast Cancer</arm_group_label>
    <description>Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal Cancer</arm_group_label>
    <description>Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of nutritional status</intervention_name>
    <description>Observational study. Assessment of nutritional status.</description>
    <arm_group_label>Breast Cancer</arm_group_label>
    <arm_group_label>Colorectal Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Colorectal or Breast Cancer undergoing Neoadjuvant or Adjuvant&#xD;
        pharmacological treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathological diagnosis of Colorectal Cancer or Breast Cancer&#xD;
&#xD;
          -  Must have Performance Status to undergo surgery and pharmacological treatment&#xD;
             (Adjuvant or Neoadjuvant treatment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-operable patients&#xD;
&#xD;
          -  Pacientes with poor Performance Status Eastern Cooperative Oncology Group (PS ECOG) &gt;2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rede Mater Dei de Saúde - Hospital Integrado do Câncer</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30180080</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernardo Coelho, MD</last_name>
      <phone>+5531987716731</phone>
      <email>bernardolevindo@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Maria Isabel Toulson Davisson Correia, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernardo Faria Levindo Coelho, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Maria Isabel Toulson Davisson Correia</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Nutritional Status</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Pharmacological Treatment</keyword>
  <keyword>Toxicity</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual-level informations will not be available in order to preserve patient's identity.</ipd_description>
  </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/NCT03759548
org study id: CAAE: 91570318.5.0000.5149
nct id: NCT03759548
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cancer patients undergo many different modalities of treatments. Pharmacological treatment
      should be well understood. The nutritional status is not taken into account when calculating
      drug's doses and this may have an impact in toxicity and quality of life. The present study
      proposes to evaluate the relationship between the calculation of pharmacological treatment's
      doses, the toxicity and the impact on quality of life among colorectal and breast cancer's
      patients.
Cancer patients undergo various treatment modalities depending on tumor type, location,
      disease staging, and overall clinical conditions. Pharmacological treatments and surgeries
      are fundamental therapeutic strategies in many cases and are part of the daily routine of
      integrated cancer treatment services. The calculation of pharmacological doses often takes
      into account the patient's body surface area (BSA) or only weight, without however assessing
      their nutritional status as such. The surgical procedure, on the other hand, may expose the
      patient to an inflammatory response secondary to the operative trauma that requires immediate
      reaction of the diseased organism for an adequate recovery. In this sense, the objective of
      the present study is to evaluate the relationship between the calculated medication's doses
      and the nutritional status of patients submitted topharmacological treatment with neoadjuvant
      or adjuvant intention: patients candidates for surgery. Different instruments will be used
      for nutritional assessment, as well as a questionnaire on quality of life, a specific
      criterion for evaluation of toxicities, laboratory tests and imaging. Patients will be
      observed for 1 year and the data collected will allow the analysis of possible side effects
      and the impact on quality of life.
observational model: Cohort
time perspective: Prospective
measure: Impact in Quality of Life during pharmacological treatments
time frame: 1 year
description: Impact in Quality of Life as assessed by European Organization for Research Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)
measure: Pharmacological treatment-related adverse events
time frame: 1 year
description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
arm group label: Breast Cancer
description: Breast Cancer's patients undergoing pharmacological treatments prior or after surgery.
arm group label: Colorectal Cancer
description: Colorectal Cancer's patients undergoing pharmacological treatments prior or after surgery.
intervention type: Other
intervention name: Assessment of nutritional status
description: Observational study. Assessment of nutritional status.
arm group label: Breast Cancer
arm group label: Colorectal Cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Maria Isabel Toulson Davisson Correia
investigator title: Clinical Professor
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms
sharing ipd: No
ipd description: Individual-level informations will not be available in order to preserve patient's identity.