Prehabilitation for Pelvic Cancer: Changes in Setup Variability

NCT ID: NCT03242538

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-23
• Study Completion Date: 2019-01-17

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.

Conditions

Pelvic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pelvic Exercise Intervention

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

Group Type: EXPERIMENTAL

Pelvic Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Pelvic Exercise

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Janaki Moni

Associate Professor, Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Baima, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical - Department of Orthopedics

Janaki Moni, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical - Department of Radiation Oncology

Locations

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31713056 (View on PubMed)

Other Identifiers

H00013328

Identifier Type: -

Identifier Source: org_study_id