Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
University of Cincinnati
Summary
This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.
Description
This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy. The objective is to determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must be female. 2. Patients must be 18 years old or older. 3. Any patient with invasive cervical cancer who is planned for definitive chemoradiation. 4. Plan to receive a minimum dose of 45Gy to pelvis per investigator. 5. Willing to undergo pelvic floor physical therapy. Exclusion Criteria: 1. Any previous therapeutic pelvic radiation. 2. Non-English speaking.
Interventions
- ProcedurePelvic floor physical therapy
Four weeks after completion of RT, patients will begin a standardized pelvic floor PT course. The protocol will include two 1-hour physical therapy appointments focused on pelvic floor muscle training, dilator training and education. These sessions will be 4 weeks apart and performed by a pelvic floor physical therapist.
Location
- University of CincinnatiCincinnati, Ohio