Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Not Applicable

Recruiting

• Conditions: Anal Cancer
• Interventions: Device: special tampon with a diameter of 28mm; Device: standard tampon with a diameter of 12-13mm

• Registration Number: NCT04094454
• Lead Sponsor: Juergen Debus

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-19
• Study Start: 2019-10-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tampon with extended vaginal dilatation	special tampon with a diameter of 28mm	Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
Commercially available tampon	standard tampon with a diameter of 12-13mm	Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

Primary Outcome Measures

Name	Time	Method
incidence and grade of vaginal fibrosis	Up to 12 months after start of (chemo)radiotherapy	during and after radiotherapy, clinical symptoms are assessed and graded

Secondary Outcome Measures

Name	Time	Method
assessment of the compliance for the use of a vaginal dilatator	continously at every follow-up visit	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
clinical symptoms and toxicity according to the CTC AE version 5.0. criteria	weekly during radiotherapy, at each follow-up visit	during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria
clinical feasibility of daily use of a special tampon	continously during radiotherapy	daily assessment of the clinical feasibility of daily use of a special tampon
assessment of quality of life	baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy	EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life

Trial Locations

Locations (1)

University Hospital of Heidelberg, Radiation Oncology; 🇩🇪 Heidelberg, Germany