Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

NCT04094454 | Recruiting

• 1 other identifier: RADONK-DILANA-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Cancer

Keywords

female patients; quality of life; vaginal dilator; vaginal fibrosis

Outcome Measures

Primary Outcomes (1)

• incidence and grade of vaginal fibrosis

  during and after radiotherapy, clinical symptoms are assessed and graded

  Up to 12 months after start of (chemo)radiotherapy

Secondary Outcomes (4)

• clinical symptoms and toxicity according to the CTC AE version 5.0. criteria

  weekly during radiotherapy, at each follow-up visit

• clinical feasibility of daily use of a special tampon

  continously during radiotherapy

• assessment of the compliance for the use of a vaginal dilatator

  continously at every follow-up visit

• assessment of quality of life

  baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy

Study Arms (2)

Tampon with extended vaginal dilatation

EXPERIMENTAL

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

Device: special tampon with a diameter of 28mm

Commercially available tampon

ACTIVE COMPARATOR

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

Interventions

special tampon with a diameter of 28mm DEVICE

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

Tampon with extended vaginal dilatation

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

Commercially available tampon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient
• Histologically confirmed squamous anal cancer
• Indication for definitive or postoperative radiotherapy
• ECOG 0-2
• Age \> 18 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Juergen Debus: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

• Arians N, Hafner M, Krisam J, Lang K, Wark A, Koerber SA, Hommertgen A, Debus J. Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial. BMC Cancer. 2020 Jan 21;20(1):52. doi: 10.1186/s12885-020-6547-7.

  PMID: 31964381 DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Nathalie Arians, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Arians, MD

CONTACT

+49 6221 568202; nathalie.arians@med.uni-heidleberg.de

Matthias Haefner, MD

CONTACT

+49 6221 568202; matthias.heafner@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Ivestigator

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 19, 2019
• Study Start: October 1, 2019
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)