Early pelvic floor physical therapy after pelvic radiation for cervical cancer

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

This will try pelvic floor physical therapy starting four weeks after pelvic radiation to see if it lowers fecal incontinence in women treated for cervical cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Cincinnati (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT07447895 on ClinicalTrials.gov

What this trial studies

This single-arm Phase II study will enroll 28 women receiving definitive pelvic external beam radiation (minimum 45 Gy) with chemoradiation for invasive cervical cancer. Participants will begin pelvic floor physical therapy four weeks after completing radiation and will be followed for outcomes. The primary endpoint is the rate of fecal incontinence at three months after radiation measured by the EORTC QLQ-CX24, with any score of 1 or higher classified as incontinence. The trial excludes patients with prior therapeutic pelvic radiation and non-English speakers and is conducted at the University of Cincinnati.

Who should consider this trial

Good fit: Women aged 18 or older with invasive cervical cancer planned for definitive pelvic external beam chemoradiation (minimum 45 Gy) who are willing to undergo pelvic floor physical therapy and can attend in-person visits in English.

Not a fit: Patients with prior therapeutic pelvic radiation or those who cannot attend in-person, English-language pelvic floor physical therapy sessions would not be eligible and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, early pelvic floor physical therapy could reduce post-radiation fecal incontinence and improve bowel-related quality of life for affected patients.

How similar studies have performed: Pelvic floor physical therapy has demonstrated benefit for other pelvic floor disorders, but there is limited prior data specifically testing early therapy after pelvic radiation, so this application is relatively novel.

Eligibility criteria

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.

Where this trial is running

Cincinnati, Ohio

• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: UCCC Clinical Trials Office

Conditions Cervical Cancer; Radiation Therapy Complication; Pelvic Floor Disorders