Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

Gynecologic Cancer Clinical Trial

Official title:

Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769062
• Other study ID #: 202209105
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: Washington University School of Medicine
• Contact: Tyler McKinnish, M.D.
• Phone: 828-734-8675
• Email: tyler.mckinnish[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Procedure:
• Single digit pelvic exam
The exam takes approximately 5 minutes and uses a single digit to palpate the pelvic floor muscles, during which patients will rate pain on a scale of 0-10 at 5 paired locations.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam	An exam will be considered positive for PFMD if pain at any examined site is reported as greater than or equal to four (>4) out of 10. The EORTC QLQ-CX2 contains 24 items scored 1-4 by frequency with which the patient experiences each. The minimum possible score is 24, and maximum 96, with higher scores indicating worse quality of life. The questionnaire will be considered positive if any vaginal, sexual, or genitourinary module question is rated 4 and otherwise will be analyzed as a continuous variable.	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
Primary	Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam	An exam will be considered positive for PFMD if pain at any examined site is reported as >4 out of 10. The PFDI-20 includes 20 items in three domains and provides a scaled score of 0-100 indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire will be considered positive if the scaled score is greater than or equal to 16, indicating at least "moderate distress" and otherwise will be analyzed as a continuous variable.	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
Primary	Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam	An exam will be considered positive for PFMD if pain at any examined site is reported as >4 out of 10. The PFIQ-7 includes 7 items each repeated across three domains and provides a scaled score and total score indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire does not have an established severity scale, and therefore will be analyzed as a simple continuous variable.	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	Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using pelvic exam	Continuous variables of scales and total scores will be calculated for the exam at each time point and represented in spider-type plots. Results of the exam will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.	Through completion of follow-up (estimated to be 6 months)
Secondary	Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the EORTC QLQ-CX2 scores	Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.	Through completion of follow-up (estimated to be 6 months)
Secondary	Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFDI-20 scores	Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.	Through completion of follow-up (estimated to be 6 months)
Secondary	Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFIQ-7 scores	Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.	Through completion of follow-up (estimated to be 6 months)
Secondary	Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam	Continuous variables of scales and total scores, as well as specific scores for radiation-exposed structures on exam, will be compared to dosimetric assessments of exposure of pelvic floor structures.	Through completion of follow-up (estimated to be 6 months)
Secondary	Determine structure level radiation dose to complex functional pelvic structures	Standard dosimetric values will be calculated for each specific pelvic floor structure evaluated on exam.	Through completion of follow-up (estimated to be 6 months)
Secondary	Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls	Historical controls will be queried via chart review for dosimetric values in archived radiation treatment plans and compared to current gynecologic radiation standards. These patients will also undergo thorough chart review for subsequent diagnoses of pelvic floor-related disorders and compared to the diagnosis rate using the proposed screening tools in this study.	Through completion of follow-up (estimated to be 6 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine