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Trial Title:
Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
NCT ID:
NCT05769062
Condition:
Gynecologic Cancer
Conditions: Keywords:
cervical cancer
radiation
chemoradiation
pelvic floor muscle dysfunction
chronic pelvic pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Single digit pelvic exam
Description:
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.
Arm group label:
Single-digit pelvic exam
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tyler McKinnish, M.D.
Phone:
828-734-8675
Email:
tyler.mckinnish@wustl.edu
Investigator:
Last name:
Tyler McKinnish, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Stephanie Markovina, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Julie Schwarz, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Premal Thaker, M.D.
Email:
Sub-Investigator
Start date:
May 30, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05769062
http://www.siteman.wustl.edu
