Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

The Washington University

Status: Terminated

Conditions: Gynecologic Cancer

Treatments: Procedure: Single digit pelvic exam

Study type: Interventional

Funder types: Other

Identifiers

NCT05769062

202209105

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Single-digit pelvic exam

Experimental group

Description:

* Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points. * The patient will also undergo a standard of care MRI prior to starting treatment.

Treatment:

Procedure: Single digit pelvic exam