RecruitingNot ApplicableNCT04094454

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study

Sponsor

Juergen Debus

Enrollment

60 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Anal Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether vaginal dilation — using a medical device during pelvic radiation therapy — can prevent the vagina from narrowing or scarring in women being treated for anal cancer. Narrowing of the vagina (vaginal stenosis) can be a side effect of pelvic radiation and affects quality of life. **You may be eligible if...** - You are a woman over 18 - You have been diagnosed with squamous cell cancer of the anus, confirmed by biopsy - You are about to receive radiation therapy to the pelvis as part of your cancer treatment - You are in reasonable health (ECOG 0–2) **You may NOT be eligible if...** - You are unable or unwilling to give consent - Vaginal dilation is not physically possible before radiation starts - You have had radiation to the pelvis before (with overlapping fields) - You are pregnant or breastfeeding, or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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