NCT03242538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

July 31, 2017

Last Update Submit

September 10, 2019

Conditions

Pelvic Cancer

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Sacral Slope Variation

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

    Daily, through duration of radiation treatment, averaging 6-10 weeks

Study Arms (1)

Pelvic Exercise Intervention

EXPERIMENTAL

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

Behavioral: Pelvic Exercise

Interventions

Pelvic ExerciseBEHAVIORAL

Hip extension and external hip rotation exercises are completed prior to daily external beam radiation treatment.

Pelvic Exercise Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • 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.

    PMID: 31713056DERIVED

MeSH Terms

Conditions

Pelvic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBehavior

Study Officials

  • Jennifer Baima, MD

    UMass Medical - Department of Orthopedics

    PRINCIPAL INVESTIGATOR

  • Janaki Moni, MD

    UMass Medical - Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Radiation Oncology

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 8, 2017

Study Start

June 23, 2017

Primary Completion

July 21, 2018

Study Completion

January 17, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)