Cervical CancerNCT07447895
Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
A study testing Pelvic floor physical therapy in people with Cervical Cancer and Radiation Therapy Complication, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Radiation Therapy Complication, Pelvic Floor Disorders
- What is being tested?
- Pelvic floor physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to 16 Apr 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be female.
- Patients must be 18 years old or older.
- Any patient with invasive cervical cancer who is planned for definitive chemoradiation.
- Plan to receive a minimum dose of 45Gy to pelvis per investigator.
- Willing to undergo pelvic floor physical therapy.
Who cannot join
- Any previous therapeutic pelvic radiation.
- Non-English speaking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Sittenfeld contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
UCCC Clinical Trials Office
Sarah Sittenfeld
About this study
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.
Read the 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.
- Being tested
- Pelvic floor physical therapy
- Medical subject headings
- Uterine Cervical Neoplasms, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor physical therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor physical therapy | Experimental | 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. Receives: Procedure: Pelvic floor physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey
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.
Measured: 3 months after Radiation Therapy Treatment
Secondary outcomes (5)
Rates of urinary incontinence via EORTC-QLQ CX24
- To determine the rates of urinary incontinence 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.
- Secondary endpoints will include rates of urinary incontinence as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
Measured: 3 months after Radiation Therapy Treatment
Sexual symptoms via EORTC-QLQ CX24
- To determine sexual symptoms at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.
- Secondary endpoints will include rates of sexual symptoms as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
Measured: 3 months after Radiation Therapy Treatment
QOL as obtained from the EORTC-QLQ CX24
- To determine QOL at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.
- Secondary endpoints will include QOL as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
Measured: 3 months after Radiation Therapy Treatment
Compliance rates with recommended standard of care schedule of dilator via self reports
- To determine compliance rates with recommended standard of care schedule of dilator use at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.
- Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage.
- Reported dilator compliance will be compared to reported historical compliance rates for this SOC recommendation
Measured: 3 months after Radiation Therapy Treatment
Evaluate changes in pelvic floor muscle function using the validated Brink scale
- To evaluate changes in pelvic floor muscle function at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.
- Descriptive analysis of pelvic floor muscle function (strength, coordination, endurance objectively graded using the validated Brink scale) at baseline and follow up, along with participant reported compliance with home exercise course will also be collected and reported.
Measured: At Baseline and at 3 months after Radiation Therapy Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start16 Apr 2026
- Primary completion16 Apr 2029 (estimated)
- Study completion16 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Sittenfeld, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447895
- Sponsor's protocol ID
- UCCC-RT-25-05
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided