Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies

Purpose

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.

Conditions

  • Cervical Cancer
  • Radiation Therapy Complication
  • Pelvic Floor Disorders

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model 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.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pelvic floor physical therapy 		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.
  • Procedure: Pelvic 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.

Recruiting Locations

University of Cincinnati
Cincinnati, Ohio 45219
Contact:
UCCC Clinical Trials Office

More Details

Status
Recruiting
Sponsor
University of Cincinnati

Study Contact

UCCC Clinical Trials Office
513-584-7698
cancer@uchealth.com

Detailed 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.