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Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

ConditionAnal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJuergen Debus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Female patient

Histologically confirmed squamous anal cancer

Indication for definitive or postoperative radiotherapy

ECOG 0-2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • special tampon with a diameter of 28mm

    Device

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

  • standard tampon with a diameter of 12-13mm

    Device

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tampon with extended vaginal dilatationExperimental treatment 1 intervention
Group B: Commercially available tamponActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juergen Debus

Lead sponsor

University Hospital Heidelberg

Sponsor institution

Source ClinicalTrials.gov
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