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Pelvic Exam Tool for Gynecologic Cancer Survivors

N/A

Recruiting

Led By Tyler McKinnish, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new exam-based tool to identify areas of injury from pelvic radiation & could lead to preventive strategies & exclusion of pain-causing areas from radiation fields.

Who is the study for?

This trial is for adult English-speaking women undergoing primary treatment for advanced cervical cancer with specific chemotherapy and radiation intended to cure. They must be willing to consent to the study's procedures.

What is being tested?

The study aims to create a standard method for assessing pelvic floor health in patients receiving pelvic radiation, using an exam-based tool and MRI planning, which may help avoid radiating sensitive areas.

What are the potential side effects?

While not explicitly listed, potential side effects could include discomfort during the pelvic exam and exposure risks associated with additional MRIs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam

Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam

Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam

Secondary study objectives

Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam

Determine structure level radiation dose to complex functional pelvic structures

Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-digit pelvic examExperimental Treatment1 Intervention

* 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.

Do I qualify?Apply below to find out