<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/NCT03796845</url>
  </required_header>
  <id_info>
    <org_study_id>Shoulder exercise cancer</org_study_id>
    <nct_id>NCT03796845</nct_id>
  </id_info>
  <brief_title>Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery</brief_title>
  <acronym>exercise</acronym>
  <official_title>Limited Versus No-limited Shoulder Movement in Breast Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cancer, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Cancer, Brazil</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized clinical trial that will include women aged 18 or older, submitted a curative&#xD;
      surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated&#xD;
      into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for&#xD;
      flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º&#xD;
      amplitude flexion and abduction of shoulder, until withdrawal surgical points).&#xD;
      Sociodemographic and clinical data will be collected through interviews, questionnaires and&#xD;
      electronic and physical records. The outcomes will be incidence of operative wound&#xD;
      complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome&#xD;
      through the physical examination, performed by the nursing and physiotherapy team throughout&#xD;
      the intervention period, ending in the 30-day post-operatory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer treatment has been accompanying advances in technology, surgeries are more&#xD;
      conservative, however postoperative complications are still observed. At early postoperative&#xD;
      period, the most common operative wound complications are seroma, infection and necrosis.&#xD;
      Shoulder dysfunctions are a frequent complication and difficult women to return to their&#xD;
      activities. There is no consensus regarding the onset and type of exercise in postoperative&#xD;
      period. Thus, the objective of this study is to compare the active no-limited mobilization&#xD;
      with limited mobilization in the immediate post operatory at the incidence of wound&#xD;
      complications in women submitted to surgery for the treatment of breast cancer.&#xD;
&#xD;
      It's a randomized clinical trial that will include women aged 18 years or older, submitted a&#xD;
      curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de&#xD;
      Janeiro. All patients admitted for surgical treatment at the institution and during the study&#xD;
      period will be evaluated for eligibility criteria. Those considered eligible for the study&#xD;
      will be clarified regarding the objectives, treatment groups, adverse effects and&#xD;
      non-compulsory participation of the study. Upon acceptance to participate, they will be&#xD;
      allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement&#xD;
      with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited&#xD;
      movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal&#xD;
      surgical points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Patients submitted to surgery for breast cancer will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence or absence of wound complications.</measure>
    <time_frame>Thirty days of follow-up</time_frame>
    <description>Occurrence of wound complications (necrosis, dehiscence, seroma, infection or hematoma) will be obtained by the physical examination, performed routinely by the nursing and physiotherapy during the first month after the surgical procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of upper limb functionality</measure>
    <time_frame>Thirty days of follow-up</time_frame>
    <description>Performed routinely by physical therapy using the upper limb functionality questionnaire (Disabilities of the arm, shoulder and hand - DASH) during the first month after the surgical procedure. It is a validated, reliable and translated into Portuguese questionnaire. It has 30 items classified from 1 to 5, and aims to grade physical function and symptoms in people with any upper limb dysfunction. The total score ranges from 0 (no dysfunction) to 100 (severe dysfunction).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of shoulder's range of motion</measure>
    <time_frame>Thirty days of follow-up</time_frame>
    <description>Performed routinely by the physiotherapist through physical examination of the range of motion of the shoulder during the first month after the surgical procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">465</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>No-limited movement after surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limited movement after surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants should move their arms with restricted movements on the first postoperative day, with maximum amplitude of 90º for flexion and abduction of the shoulder, until withdrawal surgical points. Actual hospital's routine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No limited movement after surgery</intervention_name>
    <description>Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.</description>
    <arm_group_label>Limited movement after surgery</arm_group_label>
    <arm_group_label>No-limited movement after surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 and over;&#xD;
&#xD;
          -  Indication of curative surgical treatment for breast cancer axillary approach at&#xD;
             Hospital do Câncer III / INCA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral breast cancer;&#xD;
&#xD;
          -  Surgical treatment and / or previous radiotherapy for breast cancer;&#xD;
&#xD;
          -  Reconstruction surgery;&#xD;
&#xD;
          -  Functional alteration in upper limbs prior to diagnosis of breast cancer;&#xD;
&#xD;
          -  Illiterate women who are not able to read and complete the protocol of adhesion;&#xD;
&#xD;
          -  Women who are not able to answer questions clearly;&#xD;
&#xD;
          -  Age over 80.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anke Bergmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>CPQ - INCA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clarice Gomes Chagas Teodozio</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20230240</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 3, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 4, 2020</last_update_submitted>
  <last_update_submitted_qc>April 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Cancer, Brazil</investigator_affiliation>
    <investigator_full_name>Anke Bergmann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03796845
org study id: Shoulder exercise cancer
nct id: NCT03796845
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Randomized clinical trial that will include women aged 18 or older, submitted a curative
      surgery for breast cancer at Hospital do Câncer III (HCIII-INCA). Patients will be allocated
      into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for
      flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º
      amplitude flexion and abduction of shoulder, until withdrawal surgical points).
      Sociodemographic and clinical data will be collected through interviews, questionnaires and
      electronic and physical records. The outcomes will be incidence of operative wound
      complications, like edema, joint restraint, winged scapula, pain, axillary web syndrome
      through the physical examination, performed by the nursing and physiotherapy team throughout
      the intervention period, ending in the 30-day post-operatory.
Breast cancer treatment has been accompanying advances in technology, surgeries are more
      conservative, however postoperative complications are still observed. At early postoperative
      period, the most common operative wound complications are seroma, infection and necrosis.
      Shoulder dysfunctions are a frequent complication and difficult women to return to their
      activities. There is no consensus regarding the onset and type of exercise in postoperative
      period. Thus, the objective of this study is to compare the active no-limited mobilization
      with limited mobilization in the immediate post operatory at the incidence of wound
      complications in women submitted to surgery for the treatment of breast cancer.

      It's a randomized clinical trial that will include women aged 18 years or older, submitted a
      curative surgery for breast cancer at Hospital do Câncer III (HCIII-INCA) located in Rio de
      Janeiro. All patients admitted for surgical treatment at the institution and during the study
      period will be evaluated for eligibility criteria. Those considered eligible for the study
      will be clarified regarding the objectives, treatment groups, adverse effects and
      non-compulsory participation of the study. Upon acceptance to participate, they will be
      allocated to the respective intervention groups. Group 1 - upper limbs no-limited movement
      with amplitude above 90º for flexion and abduction of shoulder; Group 2 - upper limbs limited
      movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal
      surgical points.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients submitted to surgery for breast cancer will be allocated into two groups: Intervention (upper limbs no-limited movement with amplitude above 90º for flexion and abduction of shoulder) and Control (upper limbs limited movement at maximum 90º amplitude flexion and abduction of shoulder, until withdrawal surgical points).
primary purpose: Treatment
masking: None (Open Label)
measure: Presence or absence of wound complications.
time frame: Thirty days of follow-up
description: Occurrence of wound complications (necrosis, dehiscence, seroma, infection or hematoma) will be obtained by the physical examination, performed routinely by the nursing and physiotherapy during the first month after the surgical procedure.
measure: Measurement of upper limb functionality
time frame: Thirty days of follow-up
description: Performed routinely by physical therapy using the upper limb functionality questionnaire (Disabilities of the arm, shoulder and hand - DASH) during the first month after the surgical procedure. It is a validated, reliable and translated into Portuguese questionnaire. It has 30 items classified from 1 to 5, and aims to grade physical function and symptoms in people with any upper limb dysfunction. The total score ranges from 0 (no dysfunction) to 100 (severe dysfunction).
measure: Measurement of shoulder's range of motion
time frame: Thirty days of follow-up
description: Performed routinely by the physiotherapist through physical examination of the range of motion of the shoulder during the first month after the surgical procedure.
arm group label: No-limited movement after surgery
arm group type: Experimental
description: Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.
arm group label: Limited movement after surgery
arm group type: Active Comparator
description: Participants should move their arms with restricted movements on the first postoperative day, with maximum amplitude of 90º for flexion and abduction of the shoulder, until withdrawal surgical points. Actual hospital's routine.
intervention type: Other
intervention name: No limited movement after surgery
description: Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.
arm group label: Limited movement after surgery
arm group label: No-limited movement after surgery
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anke Bergmann
role: Principal Investigator
affiliation: CPQ - INCA
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Cancer, Brazil
investigator full name: Anke Bergmann
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No