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Study identifier: NCT04094454 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Condition: Anal Cancer  ·  Sponsor: Juergen Debus

PhaseNA
Planned participants60
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nathalie Arians, MD  ·  +49 6221 568202  ·  nathalie.arians@med.uni-heidleberg.de

Matthias Haefner, MD  ·  +49 6221 568202  ·  matthias.heafner@med.uni-heidelberg.de

Always discuss trial participation with your own doctor first.

Locations (1)

University Hospital of Heidelberg, Radiation OncologyHeidelberg, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT04094454