Clinical trial NCT05769062: Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
Official title: Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Keywords: cervical cancer
radiation
chemoradiation
pelvic floor muscle dysfunction
chronic pelvic pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.


Eligibility criteria: Inclusion Criteria - Prospective Cohort

* Undergoing primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent).
* At least 18 years of age.
* English speaker.
* Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria - Prospective Cohort

* Received any form of pelvic radiation (excepting diagnostic studies).
* Currently taking and does not plan to take anti-estrogenic hormonal therapy.
* Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease.
* Currently being treated for a chronic non-cancer pain condition (treatment for pain after enrollment is acceptable).

Inclusion Criteria - Retrospective Cohort (historical control)

* Received primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent).
* At least 18 years of age.

Exclusion Criteria - Retrospective Cohort (historical control)

* Received any form of pelvic radiation (excepting diagnostic studies).
* Took anti-estrogenic hormonal therapy during treatment or in the 6 months following treatment.
* Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease at the start of treatment.
* Simultaneously treated for a chronic non-cancer pain condition at the start of treatment.

Primary outcomes:
measure: Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam
timeFrame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
measure: Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam
timeFrame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
measure: Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam
timeFrame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
Secondary outcomes:
measure: Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using pelvic exam
timeFrame: Through completion of follow-up (estimated to be 6 months)
measure: Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the EORTC QLQ-CX2 scores
timeFrame: Through completion of follow-up (estimated to be 6 months)
measure: Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFDI-20 scores
timeFrame: Through completion of follow-up (estimated to be 6 months)
measure: Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFIQ-7 scores
timeFrame: Through completion of follow-up (estimated to be 6 months)
measure: Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam
timeFrame: Through completion of follow-up (estimated to be 6 months)
measure: Determine structure level radiation dose to complex functional pelvic structures
timeFrame: Through completion of follow-up (estimated to be 6 months)
measure: Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls
timeFrame: Through completion of follow-up (estimated to be 6 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Premal Thaker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: