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Prehabilitation for Pelvic Cancer: Changes in Setup Variability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242538
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janaki Moni, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Pelvic Cancer Behavioral: Pelvic Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prehabilitation for Port Films: Phase 1. Evaluating Orthopedic Measurements of Pelvic Tilt During Radiation Treatments for Pelvic Cancer
Actual Study Start Date : June 23, 2017
Actual Primary Completion Date : July 21, 2018
Actual Study Completion Date : January 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pelvic Exercise Intervention
Patients will perform two pelvic exercises prior to each external beam radiation treatment.
Behavioral: Pelvic Exercise
Hip extension and external hip rotation exercises are completed prior to daily external beam radiation treatment.




Primary Outcome Measures :
  1. Sacral Slope Variation [ Time Frame: Daily, through duration of radiation treatment, averaging 6-10 weeks ]
    Reduced variation in sacral slope angle measured on daily port films.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242538


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Jennifer Baima, MD UMass Medical - Department of Orthopedics
Principal Investigator: Janaki Moni, MD UMass Medical - Department of Radiation Oncology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janaki Moni, Associate Professor, Department of Radiation Oncology, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03242538    
Other Study ID Numbers: H00013328
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janaki Moni, University of Massachusetts, Worcester:
Exercise
Additional relevant MeSH terms:
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Pelvic Neoplasms
Neoplasms by Site
Neoplasms