Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any previous therapeutic pelvic radiation.
Non-English speaking.
Trial design
Design model
Single group
Treatments tested in this trial
Pelvic floor physical therapy
Procedure/SurgeryFour 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.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Pelvic floor physical therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months after Radiation Therapy TreatmentSecondary outcomes
1
Rates of urinary incontinence via EORTC-QLQ CX24
1\. To determine the rates of urinary incontinence 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Secondary endpoints will include rates of urinary incontinence as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
Time frame
3 months after Radiation Therapy Treatment2
Sexual symptoms via EORTC-QLQ CX24
1\. To determine sexual symptoms at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Secondary endpoints will include rates of sexual symptoms as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
Time frame
3 months after Radiation Therapy Treatment3
QOL as obtained from the EORTC-QLQ CX24
1\. To determine QOL at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Secondary endpoints will include QOL as obtained from the EORTC-QLQ CX24 at 3-months post-treatment.
Time frame
3 months after Radiation Therapy Treatment4
Compliance rates with recommended standard of care schedule of dilator via self reports
2\. 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. 1. Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage. 2. Reported dilator compliance will be compared to reported historical compliance rates for this SOC recommendation
Time frame
3 months after Radiation Therapy TreatmentSponsors and contacts
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Source ClinicalTrials.gov