<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/NCT03242538</url>
  </required_header>
  <id_info>
    <org_study_id>H00013328</org_study_id>
    <nct_id>NCT03242538</nct_id>
  </id_info>
  <brief_title>Prehabilitation for Pelvic Cancer: Changes in Setup Variability</brief_title>
  <official_title>Prehabilitation for Port Films: Phase 1. Evaluating Orthopedic Measurements of Pelvic Tilt During Radiation Treatments for Pelvic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators hypothesize that two pelvic relaxation exercises will be feasible and safe&#xD;
      to perform by subjects daily before radiation during the participant's treatment and will&#xD;
      decrease variability of sacral slope measurements on daily port films. The investigators will&#xD;
      observe trends in the daily variability and change in the sacral slope in each participant to&#xD;
      determine if this could decrease variability. The investigators will compare these&#xD;
      measurements to a retrospective cohort that did not have the exercises, but did demonstrate&#xD;
      variability. Reducing set-up variability (which inadvertently occurs during radiation) is&#xD;
      important to improve radiation targets and diminish potential adverse effects. The&#xD;
      investigators will query participants for objective and subjective feedback on the exercises&#xD;
      and record frequency and duration of the two exercises.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2017</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sacral Slope Variation</measure>
    <time_frame>Daily, through duration of radiation treatment, averaging 6-10 weeks</time_frame>
    <description>Reduced variation in sacral slope angle measured on daily port films.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Pelvic Cancer</condition>
  <arm_group>
    <arm_group_label>Pelvic Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will perform two pelvic exercises prior to each external beam radiation treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pelvic Exercise</intervention_name>
    <description>Hip extension and external hip rotation exercises are completed prior to daily external beam radiation treatment.</description>
    <arm_group_label>Pelvic Exercise Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be &gt;21 yrs of age and will have an oncologic diagnosis that requires a&#xD;
             course of pelvic radiation therapy for a minimum of 5 weeks.&#xD;
&#xD;
          -  They will have an ECOG Performance Status (This scale, developed by the Eastern&#xD;
             Cooperative Oncology Group (ECOG), now part of the ECOG-ACRIN (American College of&#xD;
             Radiology Imaging Network) Cancer Research Group, describes a patient's level of&#xD;
             functioning in terms of their ability to care for themselves, daily activity, and&#xD;
             physical ability (walking, working, etc.)) of 1 or better as determined by patient&#xD;
             history.&#xD;
&#xD;
          -  They will be ambulatory without needing any ambulatory aids such as a cane or walker.&#xD;
&#xD;
          -  Both men and women will be eligible as there is no significant anatomical difference&#xD;
             in sacral slope measurement. Joint replacement patients will not be excluded.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Non-English speaking subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Baima, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMass Medical - Department of Orthopedics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janaki Moni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMass Medical - Department of Radiation Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Janaki Moni</investigator_full_name>
    <investigator_title>Associate Professor, Department of Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic 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/NCT03242538
org study id: H00013328
nct id: NCT03242538
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that two pelvic relaxation exercises will be feasible and safe
      to perform by subjects daily before radiation during the participant's treatment and will
      decrease variability of sacral slope measurements on daily port films. The investigators will
      observe trends in the daily variability and change in the sacral slope in each participant to
      determine if this could decrease variability. The investigators will compare these
      measurements to a retrospective cohort that did not have the exercises, but did demonstrate
      variability. Reducing set-up variability (which inadvertently occurs during radiation) is
      important to improve radiation targets and diminish potential adverse effects. The
      investigators will query participants for objective and subjective feedback on the exercises
      and record frequency and duration of the two exercises.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sacral Slope Variation
time frame: Daily, through duration of radiation treatment, averaging 6-10 weeks
description: Reduced variation in sacral slope angle measured on daily port films.
arm group label: Pelvic Exercise Intervention
arm group type: Experimental
description: Patients will perform two pelvic exercises prior to each external beam radiation treatment.
intervention type: Behavioral
intervention name: Pelvic Exercise
description: Hip extension and external hip rotation exercises are completed prior to daily external beam radiation treatment.
arm group label: Pelvic Exercise Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Baima, MD
role: Principal Investigator
affiliation: UMass Medical - Department of Orthopedics
last name: Janaki Moni, MD
role: Principal Investigator
affiliation: UMass Medical - Department of Radiation Oncology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Janaki Moni
investigator title: Associate Professor, Department of Radiation Oncology
mesh term: Pelvic Neoplasms
sharing ipd: No