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Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
Sponsor: Juergen Debus
Summary
A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \<20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \>35-49% as Grade 3 and a reduction \>/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.
Official title: Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2019-10-01
Completion Date
2027-04
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
special tampon with a diameter of 28mm
patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy
standard tampon with a diameter of 12-13mm
patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
Locations (1)
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany