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Prehabilitation for Pelvic Cancer: Changes in Setup Variability

Primary Purpose

Pelvic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic Exercise
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Cancer focused on measuring Exercise

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be >21 yrs of age and will have an oncologic diagnosis that requires a course of pelvic radiation therapy for a minimum of 5 weeks.
  • They will have an ECOG Performance Status (This scale, developed by the Eastern Cooperative Oncology Group (ECOG), now part of the ECOG-ACRIN (American College of Radiology Imaging Network) Cancer Research Group, describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.)) of 1 or better as determined by patient history.
  • They will be ambulatory without needing any ambulatory aids such as a cane or walker.
  • Both men and women will be eligible as there is no significant anatomical difference in sacral slope measurement. Joint replacement patients will not be excluded.

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Non-English speaking subjects

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pelvic Exercise Intervention

Arm Description

Patients will perform two pelvic exercises prior to each external beam radiation treatment.

Outcomes

Primary Outcome Measures

Sacral Slope Variation
Reduced variation in sacral slope angle measured on daily port films.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2017
Last Updated
September 10, 2019
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT03242538
Brief Title
Prehabilitation for Pelvic Cancer: Changes in Setup Variability
Official Title
Prehabilitation for Port Films: Phase 1. Evaluating Orthopedic Measurements of Pelvic Tilt During Radiation Treatments for Pelvic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
July 21, 2018 (Actual)
Study Completion Date
January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Cancer
Keywords
Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Exercise Intervention
Arm Type
Experimental
Arm Description
Patients will perform two pelvic exercises prior to each external beam radiation treatment.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Exercise
Intervention Description
Hip extension and external hip rotation exercises are completed prior to daily external beam radiation treatment.
Primary Outcome Measure Information:
Title
Sacral Slope Variation
Description
Reduced variation in sacral slope angle measured on daily port films.
Time Frame
Daily, through duration of radiation treatment, averaging 6-10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be >21 yrs of age and will have an oncologic diagnosis that requires a course of pelvic radiation therapy for a minimum of 5 weeks. They will have an ECOG Performance Status (This scale, developed by the Eastern Cooperative Oncology Group (ECOG), now part of the ECOG-ACRIN (American College of Radiology Imaging Network) Cancer Research Group, describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.)) of 1 or better as determined by patient history. They will be ambulatory without needing any ambulatory aids such as a cane or walker. Both men and women will be eligible as there is no significant anatomical difference in sacral slope measurement. Joint replacement patients will not be excluded. Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Non-English speaking subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Baima, MD
Organizational Affiliation
UMass Medical - Department of Orthopedics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janaki Moni, MD
Organizational Affiliation
UMass Medical - Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31713056
Citation
O'Loughlin L, Lukez A, Ma Y, Baima J, Moni J. Prehabilitation for patient positioning: pelvic exercises assist in minimizing inter-fraction sacral slope variability during radiation therapy. Med Oncol. 2019 Nov 12;37(1):3. doi: 10.1007/s12032-019-1322-9.
Results Reference
derived

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Prehabilitation for Pelvic Cancer: Changes in Setup Variability

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