Symptoms and General Pathology

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Digestive System Diseases

Behaviors and Mental Disorders

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Fibrosis

Dilatation, Pathologic

Anus Neoplasms

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Gastrointestinal Diseases

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Quality of Life

Anal Cancer

Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy

Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy

special tampon with a diameter of 28mm

patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

standard tampon with a diameter of 12-13mm

Nathalie Arians, MD

Matthias Haefner, MD

Jürgen Debus, Prof. Dr.

Adriane Hommertgen

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.

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

during and after radiotherapy, clinical symptoms are assessed and graded

during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria

daily assessment of the clinical feasibility of daily use of a special tampon

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

EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy	NCT04094454	Anal Cancer	special tampon ... standard tampon...	18 Years -	University Hospital Heidelberg
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy	NCT04094454	Anal Cancer	special tampon ... standard tampon...	18 Years -	University Hospital Heidelberg

Spots Global Cancer Trial Database for special tampon with a diameter of 28mm