Clinical trial NCT03242538: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Cancer
Keywords: Exercise
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Sacral Slope Variation
timeFrame: Daily, through duration of radiation treatment, averaging 6-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical - Department of Orthopedics
name: Jennifer Baima, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Medical - Department of Radiation Oncology
name: Janaki Moni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.