<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/NCT02976363</url>
  </required_header>
  <id_info>
    <org_study_id>46913415700000021</org_study_id>
    <nct_id>NCT02976363</nct_id>
  </id_info>
  <brief_title>Maximal Respiratory Pressures After Radiotherapy</brief_title>
  <official_title>Study of Maximal Respiratory Pressures After Exposure to Breast Radiotherapy in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Mato Grosso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Mato Grosso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP)&#xD;
      after exposure to breast radiation therapy in women. Methods: Prospective observational study&#xD;
      performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this study&#xD;
      consisted of women (N = 16) divided into two groups: women exposed to breast radiotherapy&#xD;
      after underwent quadrantectomy surgery (n = 8); and women with no history of cancer (n = 8).&#xD;
      We evaluated the strength of respiratory muscles through the Maximal Inspiratory Pressure&#xD;
      (MIP) and Maximal Expiratory Pressure (MEP) using the handset called manovacuometer. The&#xD;
      examination was performed before the first session and after the twenty-fifth session related&#xD;
      to the last day of the radiation treatment; evaluation of anthropometric data of weight and&#xD;
      height to detect the body mass index (BMI); evaluation of clinical respiratory symptoms of&#xD;
      dyspnea using the Medical Research Council (MRC) Dyspnea Scale and characterization of cough&#xD;
      with Common Pulmonary Toxicity Criteria, in the classification of clinical pneumonitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and sample The research consisted of an observational prospective study with&#xD;
      control group. The study was approved by the Ethics Committee of the Federal University of&#xD;
      Mato Grosso do Sul (UFMS) with the number 46913415.7.0000.002. All participants signed an&#xD;
      informed consent form after being informed about the design and objectives of the study&#xD;
      according to Resolution 466/12 of the National Council of Health Ministry of Health (CNS).&#xD;
&#xD;
      The quadrantectomy group participants were selected consecutively among patients who&#xD;
      initiated radiotherapy. While the control group was selected during routine exams of he image&#xD;
      sector from Hospital de Cancer Alfred Abrão.&#xD;
&#xD;
      Research site The execution of the research took place in the Radiotherapy sector of Hospital&#xD;
      de Cancer Alfred Abrão in Campo Grande - Mato Grosso do Sul state, from December 2015 to&#xD;
      February 2016.&#xD;
&#xD;
      Radiotherapy Protocol The Quadrantectomy Group sample performed adjuvant radiotherapy with a&#xD;
      linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy&#xD;
      distributed into twenty-five sessions, totaling 25 days of treatment.&#xD;
&#xD;
      PROCEDURES Evaluation of maximal respiratory pressures (MRP) Quantification of MIP and MEP&#xD;
      was performed with the portable device called manometer, Wika brand with pressure scale&#xD;
      ranging from -150 to 150 centimeters of water (0 to -150 to (0 to -150 for MIP; 0 to 150 for&#xD;
      MEP). The mouthpiece attached to the device had a hole of 2 mm in diameter, in order to&#xD;
      function as a relief valve of the facial muscles. During the measurement of maximal&#xD;
      respiratory pressures, the survey participants remained in seated position with the trunk in&#xD;
      a 90 ° angle with the lower limbs. A forced expiration was requested until reaching the&#xD;
      residual volume (RV) for the measurement of MIP, followed by a maximal inspiratory effort&#xD;
      against the occluded airway (Maneuver Muller), this maneuver kept for up to 2 seconds. While&#xD;
      the evaluation of MEP, a maximum inspiration was requested to Total Lung Capacity (TLC),&#xD;
      followed by a maximal expiratory effort against the occluded airway (Muller maneuver),&#xD;
      maintained for up to 2 seconds.&#xD;
&#xD;
      Data from Maximal Respiratory Pressures were collected at two phases in the sample of&#xD;
      quadrantectomy group: before the first session of radiotherapy and after the twenty-fifth&#xD;
      session corresponding to the last day of the radiotherapy treatment.&#xD;
&#xD;
      The evaluation of the MRP was performed according to the Brazilian Guidelines for Pulmonary&#xD;
      Function Tests. The results were analyzed according to the predictive values of Neder&#xD;
      regression equations (1999).&#xD;
&#xD;
      Complementary evaluation Anthropometric data evaluated to detect the body mass index (BMI)&#xD;
      were: weight and height. Evaluation of dyspnea and cough symptoms with modified Dyspnea&#xD;
      Medical Research Council scale (MRC) with the Common Pulmonary Toxicity Common Criteria scale&#xD;
      (CTC Version 2.0) was performed to classify the clinic pneumonitis according to the Common&#xD;
      Toxicity Criteria (CTC Version 2.0).&#xD;
&#xD;
      Statistics The variables classified as dependent were the maximal respiratory pressures.&#xD;
      While the independent variables were sex, age, weight, height, BMI.&#xD;
&#xD;
      The comparison data analysis between the control group and quadrantectomy in relation to the&#xD;
      variables: age, height, weight, BMI, MIP and MEP, was performed using the student's t test.&#xD;
      The comparison between the moments before and after the radiotherapy in relation to MIP and&#xD;
      MEP was performed using the student's t test paired, considering a 5% significance level. The&#xD;
      other results of this study were presented in the form of descriptive statistics or in tables&#xD;
      and graphics. Statistical analysis was performed using the sigma plot version 12.5&#xD;
      statistical program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women</measure>
    <time_frame>three months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Respiratory Function Tests</condition>
  <arm_group>
    <arm_group_label>Quadrantectomy Group</arm_group_label>
    <description>The Quadrantectomy Group sample performed adjuvant radiotherapy with a linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy distributed into twenty-five sessions, totaling 25 days of treatment. And data from Maximal Respiratory Pressures (MIP/MEP) were collected at two phases in the sample of Quadrantectomy Group: before the first session of radiotherapy and after the twenty-fifth session corresponding to the last day of the radiotherapy treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>While for the control group women with no breast cancer history were invited. Data from Maximal Respiratory Pressures (MIP/MEP) were collected at one phase in the sample of control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy breast cancer</intervention_name>
    <arm_group_label>Quadrantectomy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation Maximal Respiratory Pressures</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Quadrantectomy Group</arm_group_label>
    <other_name>MIP and MEP</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The quadrantectomy group (QG) participants were selected consecutively among patients who&#xD;
        initiated radiotherapy. While the control group (CG) was selected during routine exams of&#xD;
        he image sector from Hospital de Cancer Alfred Abrão.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  There were selected women aged 40-70 years old, breast quadrantectomy post-surgery and&#xD;
             adjuvant radiotherapy indication to compose the experimental group.&#xD;
&#xD;
          -  While for the control group women aged 40-70 years old with no breast cancer history&#xD;
             were invited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion of the experimental and control groups were based on the following&#xD;
             criteria:&#xD;
&#xD;
          -  lung disease association, central or peripheral neurological disorders, refusal to&#xD;
             participate in the study, difficulties in understanding and the completion of the&#xD;
             protocol tests.&#xD;
&#xD;
          -  The unique criteria of the experimental group were: metastatic cancer, concomitant&#xD;
             chemotherapy to radiotherapy, hormone therapy and withdrawal of treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thays M Avila</last_name>
    <role>Principal Investigator</role>
    <affiliation>UFMS</affiliation>
  </overall_official>
  <reference>
    <citation>Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.</citation>
    <PMID>5772056</PMID>
  </reference>
  <reference>
    <citation>Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.</citation>
    <PMID>10412550</PMID>
  </reference>
  <reference>
    <citation>Spyropoulou D, Leotsinidis M, Tsiamita M, Spiropoulos K, Kardamakis D. Pulmonary function testing in women with breast cancer treated with radiotherapy and chemotherapy. In Vivo. 2009 Sep-Oct;23(5):867-71.</citation>
    <PMID>19779125</PMID>
  </reference>
  <reference>
    <citation>Lee TF, Chao PJ, Chang L, Ting HM, Huang YJ. Developing Multivariable Normal Tissue Complication Probability Model to Predict the Incidence of Symptomatic Radiation Pneumonitis among Breast Cancer Patients. PLoS One. 2015 Jul 6;10(7):e0131736. doi: 10.1371/journal.pone.0131736. eCollection 2015.</citation>
    <PMID>26147496</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Mato Grosso</investigator_affiliation>
    <investigator_full_name>Thays Mello de Avila</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Radiotherapy</keyword>
  <keyword>Respiratory muscles</keyword>
  <keyword>Neoplasms</keyword>
  <keyword>Breast</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02976363
org study id: 46913415700000021
nct id: NCT02976363
lead sponsor: 
has dmc: No
Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP)
      after exposure to breast radiation therapy in women. Methods: Prospective observational study
      performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this study
      consisted of women (N = 16) divided into two groups: women exposed to breast radiotherapy
      after underwent quadrantectomy surgery (n = 8); and women with no history of cancer (n = 8).
      We evaluated the strength of respiratory muscles through the Maximal Inspiratory Pressure
      (MIP) and Maximal Expiratory Pressure (MEP) using the handset called manovacuometer. The
      examination was performed before the first session and after the twenty-fifth session related
      to the last day of the radiation treatment; evaluation of anthropometric data of weight and
      height to detect the body mass index (BMI); evaluation of clinical respiratory symptoms of
      dyspnea using the Medical Research Council (MRC) Dyspnea Scale and characterization of cough
      with Common Pulmonary Toxicity Criteria, in the classification of clinical pneumonitis.
Study design and sample The research consisted of an observational prospective study with
      control group. The study was approved by the Ethics Committee of the Federal University of
      Mato Grosso do Sul (UFMS) with the number 46913415.7.0000.002. All participants signed an
      informed consent form after being informed about the design and objectives of the study
      according to Resolution 466/12 of the National Council of Health Ministry of Health (CNS).

      The quadrantectomy group participants were selected consecutively among patients who
      initiated radiotherapy. While the control group was selected during routine exams of he image
      sector from Hospital de Cancer Alfred Abrão.

      Research site The execution of the research took place in the Radiotherapy sector of Hospital
      de Cancer Alfred Abrão in Campo Grande - Mato Grosso do Sul state, from December 2015 to
      February 2016.

      Radiotherapy Protocol The Quadrantectomy Group sample performed adjuvant radiotherapy with a
      linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy
      distributed into twenty-five sessions, totaling 25 days of treatment.

      PROCEDURES Evaluation of maximal respiratory pressures (MRP) Quantification of MIP and MEP
      was performed with the portable device called manometer, Wika brand with pressure scale
      ranging from -150 to 150 centimeters of water (0 to -150 to (0 to -150 for MIP; 0 to 150 for
      MEP). The mouthpiece attached to the device had a hole of 2 mm in diameter, in order to
      function as a relief valve of the facial muscles. During the measurement of maximal
      respiratory pressures, the survey participants remained in seated position with the trunk in
      a 90 ° angle with the lower limbs. A forced expiration was requested until reaching the
      residual volume (RV) for the measurement of MIP, followed by a maximal inspiratory effort
      against the occluded airway (Maneuver Muller), this maneuver kept for up to 2 seconds. While
      the evaluation of MEP, a maximum inspiration was requested to Total Lung Capacity (TLC),
      followed by a maximal expiratory effort against the occluded airway (Muller maneuver),
      maintained for up to 2 seconds.

      Data from Maximal Respiratory Pressures were collected at two phases in the sample of
      quadrantectomy group: before the first session of radiotherapy and after the twenty-fifth
      session corresponding to the last day of the radiotherapy treatment.

      The evaluation of the MRP was performed according to the Brazilian Guidelines for Pulmonary
      Function Tests. The results were analyzed according to the predictive values of Neder
      regression equations (1999).

      Complementary evaluation Anthropometric data evaluated to detect the body mass index (BMI)
      were: weight and height. Evaluation of dyspnea and cough symptoms with modified Dyspnea
      Medical Research Council scale (MRC) with the Common Pulmonary Toxicity Common Criteria scale
      (CTC Version 2.0) was performed to classify the clinic pneumonitis according to the Common
      Toxicity Criteria (CTC Version 2.0).

      Statistics The variables classified as dependent were the maximal respiratory pressures.
      While the independent variables were sex, age, weight, height, BMI.

      The comparison data analysis between the control group and quadrantectomy in relation to the
      variables: age, height, weight, BMI, MIP and MEP, was performed using the student's t test.
      The comparison between the moments before and after the radiotherapy in relation to MIP and
      MEP was performed using the student's t test paired, considering a 5% significance level. The
      other results of this study were presented in the form of descriptive statistics or in tables
      and graphics. Statistical analysis was performed using the sigma plot version 12.5
      statistical program.
observational model: Cohort
time perspective: Prospective
measure: Maximal Respiratory Pressures (MRP) after exposure to breast radiation therapy in women
time frame: three months
arm group label: Quadrantectomy Group
description: The Quadrantectomy Group sample performed adjuvant radiotherapy with a linear accelerator, whose the total dosage was 5000 centigray (cGy), the daily dose 200 cGy distributed into twenty-five sessions, totaling 25 days of treatment. And data from Maximal Respiratory Pressures (MIP/MEP) were collected at two phases in the sample of Quadrantectomy Group: before the first session of radiotherapy and after the twenty-fifth session corresponding to the last day of the radiotherapy treatment.
arm group label: Control Group
description: While for the control group women with no breast cancer history were invited. Data from Maximal Respiratory Pressures (MIP/MEP) were collected at one phase in the sample of control group.
intervention type: Radiation
intervention name: Radiotherapy breast cancer
arm group label: Quadrantectomy Group
intervention type: Other
intervention name: Evaluation Maximal Respiratory Pressures
arm group label: Control Group
arm group label: Quadrantectomy Group
other name: MIP and MEP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thays M Avila
role: Principal Investigator
affiliation: UFMS
citation: Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.
PMID: 5772056
citation: Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
PMID: 10412550
citation: Spyropoulou D, Leotsinidis M, Tsiamita M, Spiropoulos K, Kardamakis D. Pulmonary function testing in women with breast cancer treated with radiotherapy and chemotherapy. In Vivo. 2009 Sep-Oct;23(5):867-71.
PMID: 19779125
citation: Lee TF, Chao PJ, Chang L, Ting HM, Huang YJ. Developing Multivariable Normal Tissue Complication Probability Model to Predict the Incidence of Symptomatic Radiation Pneumonitis among Breast Cancer Patients. PLoS One. 2015 Jul 6;10(7):e0131736. doi: 10.1371/journal.pone.0131736. eCollection 2015.
PMID: 26147496
responsible party type: Principal Investigator
investigator affiliation: Federal University of Mato Grosso
investigator full name: Thays Mello de Avila
investigator title: Principal Investigator
sharing ipd: No