<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/NCT02198118</url>
  </required_header>
  <id_info>
    <org_study_id>NCT01940107</org_study_id>
    <secondary_id>USP-HCarrara</secondary_id>
    <nct_id>NCT02198118</nct_id>
  </id_info>
  <brief_title>Domiciliary Physiotherapy During Breast Cancer Radiation</brief_title>
  <official_title>Domiciliary Physiotherapy During Breast Cancer Radiation</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Breast cancer is the most common type of cancer among women. Its treatment,&#xD;
      including radiotherapy (RT), can cause potential complications to be treated by the&#xD;
      physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper&#xD;
      limb applied during the period of radiotherapy in women submitted to surgical and&#xD;
      radiotherapy for breast cancer. Study design: This is a prospective randomized controlled&#xD;
      clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March&#xD;
      2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the&#xD;
      end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm&#xD;
      circumference. They were divided into two groups: CG) control group, submitted only to the&#xD;
      assessments and SG) study group, submitted to domiciliary physiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gain in range of movement measured in degrees</measure>
    <time_frame>Three months</time_frame>
    <description>The volunteers were evaluated at three distinct times: pre-RT (first evaluation), post-RT (second evaluation) and 2 months after the end of RT (third evaluation). The following parameters were evaluated: ROM of shoulder joint and upper limb perimetry. To assess shoulder ROM, the movements of flexion, extension, abduction, adduction, internal rotation and external rotation were measured, with each movement being performed by subjects. The volunteers were randomly divided into 2 groups: a control group (CG) subjected only to evaluations and to no exercise, and a study group (SG) instructed to perform domiciliary exercises for the upper limbs. The plan randomization was performed by a computer program that generated a list with the allotment of cases to the two groups. The allocation was randomized, but not concealed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of lymphedema measured in centimeters</measure>
    <time_frame>Three months</time_frame>
    <description>Lymphedema was evaluated during the period of the study through perimetry measurements that were made at 6 different points: point A -metacarpophalangeal joint of the 2nd, 3rd, 4th and 5th fingers; point B - an imaginary line passing through the metacarpophalangeal joint of the thumb; point C - 10 cm below the olecranon; point D - 6 cm below the olecranon; point E - 6 cm above the olecranon, and point F - 10 cm above the olecranon 20. The volunteer should be sitting, with her arm resting on her thigh and the forearm supinated. The measurements were bilateral and carried out by the same observer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group (CG) subjected only to evaluations and to no exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study group (SG) instructed to perform domiciliary exercises for the upper limbs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Domiciliary exercises for the upper limbs</intervention_name>
    <description>Study group (SG) instructed to perform domiciliary exercises for the upper limbs.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Having been diagnosed with unilateral breast cancer and having been submitted to surgical&#xD;
        and radiation treatment as part of the treatment for breast cancer, according to the&#xD;
        therapeutic protocol of the unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients with neurological or orthopedic diseases that could impair the movements of the&#xD;
        upper limbs, bilateral breast cancer, previous thoracic radiotherapy, and the presence of&#xD;
        distant metastasis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nara FB Leal, Master</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clínicas de Ribeirão Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>SP</state>
        <zip>14048900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Helio Carrara</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02198118
org study id: NCT01940107
secondary id: USP-HCarrara
nct id: NCT02198118
lead sponsor: 
has dmc: Yes
Background: Breast cancer is the most common type of cancer among women. Its treatment,
      including radiotherapy (RT), can cause potential complications to be treated by the
      physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper
      limb applied during the period of radiotherapy in women submitted to surgical and
      radiotherapy for breast cancer. Study design: This is a prospective randomized controlled
      clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March
      2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the
      end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm
      circumference. They were divided into two groups: CG) control group, submitted only to the
      assessments and SG) study group, submitted to domiciliary physiotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Gain in range of movement measured in degrees
time frame: Three months
description: The volunteers were evaluated at three distinct times: pre-RT (first evaluation), post-RT (second evaluation) and 2 months after the end of RT (third evaluation). The following parameters were evaluated: ROM of shoulder joint and upper limb perimetry. To assess shoulder ROM, the movements of flexion, extension, abduction, adduction, internal rotation and external rotation were measured, with each movement being performed by subjects. The volunteers were randomly divided into 2 groups: a control group (CG) subjected only to evaluations and to no exercise, and a study group (SG) instructed to perform domiciliary exercises for the upper limbs. The plan randomization was performed by a computer program that generated a list with the allotment of cases to the two groups. The allocation was randomized, but not concealed.
measure: Improvement of lymphedema measured in centimeters
time frame: Three months
description: Lymphedema was evaluated during the period of the study through perimetry measurements that were made at 6 different points: point A -metacarpophalangeal joint of the 2nd, 3rd, 4th and 5th fingers; point B - an imaginary line passing through the metacarpophalangeal joint of the thumb; point C - 10 cm below the olecranon; point D - 6 cm below the olecranon; point E - 6 cm above the olecranon, and point F - 10 cm above the olecranon 20. The volunteer should be sitting, with her arm resting on her thigh and the forearm supinated. The measurements were bilateral and carried out by the same observer.
arm group label: Control Group
arm group type: No Intervention
description: Control group (CG) subjected only to evaluations and to no exercises.
arm group label: Study Group
arm group type: Experimental
description: Study group (SG) instructed to perform domiciliary exercises for the upper limbs
intervention type: Other
intervention name: Domiciliary exercises for the upper limbs
description: Study group (SG) instructed to perform domiciliary exercises for the upper limbs.
arm group label: Study Group
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nara FB Leal, Master
role: Study Chair
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Helio Carrara
investigator title: Professor
mesh term: Shoulder Pain