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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

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

NCT ID

NCT03242538

First Posted

July 31, 2017

Last Updated

September 10, 2019

Sponsor

University of Massachusetts, Worcester

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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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