Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

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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.

Conditions:

🦠 Gynecologic Cancer

🗓️ Study Start (Actual) 30 May 2023

🗓️ Primary Completion (Estimated) 30 November 2025

✅ Study Completion (Estimated) 30 November 2025

👥 Enrollment (Estimated) 40

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 16 February 2023
First Submitted that Met QC Criteria 13 March 2023
First Posted 15 March 2023

Study Record Updates