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Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

RecruitingNAAges 18 Years - anyFemaleJuergen Debus
NCT04094454 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female patient * Histologically confirmed squamous anal cancer * Indication for definitive or postoperative radiotherapy * ECOG 0-2 * Age \> 18 years * Written informed consent Exclusion Criteria: * patients refusal or incapability of informed consent * no vaginal dilatation possible prior to radiation treatment start * prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed) * participation in another clinical trial which might influence the results of the DILANA trial * pregnancy/nursing period or inadequate contraception in women with child bearing potential
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What it tests

  • special tampon with a diameter of 28mm
  • standard tampon with a diameter of 12-13mm
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Where

1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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