This clinical trial compares the use of patient-reported symptom questionnaires to a physician-performed pelvic exam for diagnosing pelvic floor dysfunction in patients undergoing pelvic radiation for cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Patients with gynecologic malignancies are particularly susceptible to pelvic floor muscle dysfunction (PFMD), a debilitating collection of symptoms related to injury of the pelvic support structures (muscles, ligaments, and other tissues). PFMD can lead to chronic pelvic pain, impaired mobility, bowel and bladder dysfunction, and poor sexual health. The effects of radiation on the pelvic floor are understudied, but pelvic radiation may contribute to the development of PFMD in gynecologic cancer patients. An exam-based diagnostic tool may 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. Information gathered from this study may help researchers understand the parts of the pelvis that are most affected, and may be able to design better radiation treatments or use preventative techniques to protect these areas.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05769062.
PRIMARY OBJECTIVES:
I. To compare the use of patient-reported symptom questionnaires to a physician-performed exam for the diagnosis and assessment of pelvic floor dysfunction in patients undergoing primary chemoradiotherapy for locally advanced cervical cancer.
II. To determine the time course of pelvic floor muscle dysfunction evolution over the course of treatment for cervical cancer, assess the reliability of 3 patient-reported symptom questionnaires, and correlate radiation dose to pelvic floor structures with symptom severity.
III. To compare the dosimetry of traditional intensity-modulated radiation therapy (IMRT) and 3-dimensional (3D) image-guided brachytherapy (IMRT/B) to the newer split-field IMRT/B technique to determine if split-field IMRT reduces structure-level radiation dose to complex functional pelvic structures.
IV. To assess the optimal methods of contouring detailed pelvic structures, comparing magnetic resonance imaging (MRI) to computed tomography (CT) contouring by evaluating the frequency of PMFD symptoms in split-field IMRT patients compared to historical controls.
OUTLINE:
PROSPECTIVE: Patients complete questionnaires, undergo single-digit pelvic floor exam, and have their medical records reviewed for data collection on study.
RETROSPECTIVE: Patients have their medical records reviewed for data collection on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorPremal H. Thaker
