Using vaginal dilators to reduce vaginal stenosis in anal cancer patients during radiotherapy
Official title: Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
Run by University Hospital Heidelberg · NCT04094454 · Data updated 2026-11-12
This study is testing whether using a larger tampon for vaginal dilation during pelvic radiotherapy can help women with anal cancer avoid problems like vaginal narrowing after treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Heidelberg) |
| Status | Recruiting |
| Started | October 1, 2019 |
| Main results expected | April 2026 |
| Study ends | April 2027 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT04094454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients over 18 years old with histologically confirmed squamous anal cancer who are scheduled for definitive or postoperative radiotherapy.
✕Probably not a fit
Patients who have previously undergone pelvic irradiation or cannot undergo vaginal dilation prior to treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of intrafractional vaginal dilation using different tampon sizes in female patients undergoing pelvic radiotherapy for anal cancer. It is a prospective, randomized, two-armed trial involving 60 patients who will be assigned to either a standard or a larger tampon for vaginal dilation during treatment. The primary goal is to assess the incidence and severity of vaginal fibrosis 12 months post-radiotherapy, with secondary endpoints including clinical symptoms, toxicity, compliance, and quality of life. The study aims to determine if the larger tampon can significantly reduce the rate of vaginal stenosis compared to the standard size.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of vaginal stenosis in anal cancer patients, improving their quality of life post-treatment.
How similar studies have gone: While similar approaches have been explored, this specific method of intrafractional vaginal dilation in the context of anal cancer treatment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany Recruiting
Study contacts
- Principal investigator: Nathalie Arians, MD — University Hospital Heidelberg
- Study coordinator: Nathalie Arians, MD
- Email: nathalie.arians@med.uni-heidleberg.de
- Phone: +49 6221 568202
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Retifanlimab after chemoradiation for anal cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.