Cervical Cancer, Radiation Therapy Complication, Pelvic Floor Disorders
Conditions
Brief 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.
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
PROCEDUREPelvic 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.
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey | 3 months after Radiation Therapy Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of urinary incontinence via EORTC-QLQ CX24 | 3 months after Radiation Therapy Treatment | 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. |
| Sexual symptoms via EORTC-QLQ CX24 | 3 months after Radiation Therapy Treatment | 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. |
| QOL as obtained from the EORTC-QLQ CX24 | 3 months after Radiation Therapy Treatment | 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. |
| Compliance rates with recommended standard of care schedule of dilator via self reports | 3 months after Radiation Therapy Treatment | 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 |
| Evaluate changes in pelvic floor muscle function using the validated Brink scale | At Baseline and at 3 months after Radiation Therapy Treatment | 3\. To evaluate changes in pelvic floor muscle function at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. 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. |
Countries
United States
Contacts
CONTACTUCCC Clinical Trials Office
CONTACTSarah Sittenfeld
Outcome results
None listed