An interventional study of special tampon with a diameter of 28mm and standard tampon with a diameter of 12-13mm in Anal Cancer, sponsored by Juergen Debus. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Juergen Debus · Not applicable, Interventional, and Other
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.
The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Juergen Debus is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
Device: special tampon with a diameter of 28mm
Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
Device: standard tampon with a diameter of 12-13mm
patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy
patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
incidence and grade of vaginal fibrosis
during and after radiotherapy, clinical symptoms are assessed and graded
Time frame: Up to 12 months after start of (chemo)radiotherapy
clinical symptoms and toxicity according to the CTC AE version 5.0. criteria
during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria
Time frame: weekly during radiotherapy, at each follow-up visit
clinical feasibility of daily use of a special tampon
daily assessment of the clinical feasibility of daily use of a special tampon
Time frame: continously during radiotherapy
assessment of the compliance for the use of a vaginal dilatator
patients will be instructed to use a vaginal dilator 3 times a week, at each follow-up visit patients are asked about the frequency of vaginal dilator use
Time frame: continously at every follow-up visit
assessment of quality of life
EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life
Time frame: baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy
Plan to share: No
Started Oct 2019 (actual). Primary completion is estimated for Apr 2026, 78 months after the start.
Of 39 interventional studies with no phase under Anus Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 17. This study's planned 78 months is above that.
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Juergen Debus