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Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

NCT04094454 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

special tampon with a diameter of 28mm

patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy

DEVICE

standard tampon with a diameter of 12-13mm

patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

Sponsors & Collaborators

  • Juergen Debus

    lead OTHER

Principal Investigators

  • Nathalie Arians, MD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2026-04-30
Completion
2027-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094454 on ClinicalTrials.gov