Anal CancerDILANANCT04094454
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy
A study testing special tampon with a diameter of 28mm and standard tampon with a diameter of 12-13mm in people with Anal Cancer, run by Juergen Debus at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Cancer
- What is being tested?
- special tampon with a diameter of 28mm and standard tampon with a diameter of 12-13mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient
- Histologically confirmed squamous anal cancer
- Indication for definitive or postoperative radiotherapy
- ECOG 0-2
- Age > 18 years
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
Jürgen Debus, Prof. Dr., +49-6221-56 ext. 8202, juergen.debus@med.uni-heidelberg.de
Adriane Hommertgen, +49-6221-56 ext. 8202, adriane.hommertgen@med.uni-heidelberg.de
About this study
Official title: Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
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.
Read the 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.
- Conditions
- Anal Cancer
- Being tested
- special tampon with a diameter of 28mm, standard tampon with a diameter of 12-13mm
- Keywords
- female patients, quality of life, vaginal dilator, vaginal fibrosis
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
special tampon with a diameter of 28mmDevice
patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy
standard tampon with a diameter of 12-13mmDevice
patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Tampon with extended vaginal dilatation | Experimental | Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy Receives: 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 Receives: Device: standard tampon with a diameter of 12-13mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and grade of vaginal fibrosis
during and after radiotherapy, clinical symptoms are assessed and graded
Measured: 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
during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria
Measured: 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
Measured: 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
Measured: continously at every follow-up visit
assessment of quality of life
EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life
Measured: baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juergen Debus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Nathalie Arians, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094454
- Sponsor's protocol ID
- RADONK-DILANA-2018
- Acronym
- DILANA
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2019
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31964381
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
- ClinicalTrials.gov ID
- NCT04094454
- Acronym / sponsor ID
- DILANA / RADONK-DILANA-2018
- Conditions
- Anal Cancer
- Keywords
- female patients, quality of life, vaginal dilator, vaginal fibrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Juergen DebusUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tampon with extended vaginal dilatation | Experimental | Device: special tampon with a diameter of 28mmPatients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy |
| Commercially available tampon | Active comparator | Device: standard tampon with a diameter of 12-13mmPatients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patient
- Histologically confirmed squamous anal cancer
- Indication for definitive or postoperative radiotherapy
- ECOG 0-2
- Age > 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| special tampon with a diameter of 28mmpatients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy | Device | Tampon with extended vaginal dilatation |
| standard tampon with a diameter of 12-13mmpatients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy | Device | Commercially available tampon |
Primary outcome
incidence and grade of vaginal fibrosis
Time frame: Up to 12 months after start of (chemo)radiotherapy
during and after radiotherapy, clinical symptoms are assessed and graded
4 secondary outcomes
clinical symptoms and toxicity according to the CTC AE version 5.0. criteria
Time frame: weekly during radiotherapy, at each follow-up visit
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
Time frame: continously at every follow-up visit
assessment of quality of life
Time frame: baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 31964381Arians 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie Arians, MD principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing special tampon with a diameter of 28mm and standard tampon with a diameter of 12-13mm in people with Anal Cancer, run by Juergen Debus at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Arians, MD (+49 6221 568202, nathalie.arians@med.uni-heidleberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and grade of vaginal fibrosis (time frame: Up to 12 months after start of (chemo)radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.