Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvic floor physical therapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Radiation Therapy Complication, Pelvic Floor Disorders. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey [Time frame: 3 months after Radiation Therapy Treatment]
Secondary outcome measures (5)
- Rates of urinary incontinence via EORTC-QLQ CX24 [Time frame: 3 months after Radiation Therapy Treatment]
- Sexual symptoms via EORTC-QLQ CX24 [Time frame: 3 months after Radiation Therapy Treatment]
- QOL as obtained from the EORTC-QLQ CX24 [Time frame: 3 months after Radiation Therapy Treatment]
- Compliance rates with recommended standard of care schedule of dilator via self reports [Time frame: 3 months after Radiation Therapy Treatment]
- Evaluate changes in pelvic floor muscle function using the validated Brink scale [Time frame: At Baseline and at 3 months after Radiation Therapy Treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Any previous therapeutic pelvic radiation.
- Non-English speaking.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Cincinnati — Cincinnati
Identifiers
NCT: NCT07447895 · UCCC-RT-25-05