Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• incidence and grade of vaginal fibrosis — Up to 12 months after start of (chemo)radiotherapy
  during and after radiotherapy, clinical symptoms are assessed and graded

Trial sites (1)

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