Anal CancerDACG VINCT07296237
Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
An observational study of Anal Cancer, run by Aarhus University Hospital at 3 sites in Denmark.
Trial summary
The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Cancer
- How many people
- 80 participants
- Where
- 3 sitesDenmark
- Study dates
- 13 Nov 2025to 1 Sep 2026
- Phase
- Observational
- 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
Study population: The study population includes adult women who have been treated with chemoradiotherapy for anal cancer in Denmark. Participants are recruited during routine follow-up visits at three oncology departments. All participants are between 6 and 36 months after treatment and are in cancer follow-up care
Who may be able to join
- Women aged 18 years or older
- Diagnosed with anal cancer
- Treated with chemoradiotherapy with curative intent
- Between 6 and 36 months since completion of radiotherapy
- Able and willing to give written informed consent
Who cannot join
- Previous pelvic radiotherapy for another disease
- Treated with electron beam radiotherapy
- Unable to speak or understand Danish
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Oncology Aarhus University Hospital (AUH)
Aarhus, 8200
Johanne H. Steffensen, MD, PhD, 004551434830, johste@oncology.au.dk
- Recruiting
Department of Oncology, Herlev and Gentofte Hospital
Herlev, 2730
Eva Serup-Hansen, MD. PhD, 004538683868, Eva.Serup-Hansen@regionh.dk
- Recruiting
Department of Oncology Vejle Hospital, University Hospital of Southern Denmark
Vejle, 7100
Lars U. Fokdal, MD, PhD, 004579405000, Lars.Ulrik.Fokdal@rsyd.dk
About this study
Official title: DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems.
The main questions this study aims to answer are:
Read more
- How many women develop moderate or severe narrowing of the vagina after radiotherapy?
- Is there a link between the radiation dose and vaginal problems?
- How do vaginal changes affect sexual health and daily life?
- What care and support do women receive, and how satisfied are they with this support?
Participants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment.
Participants will:
Have a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment
The study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study.
The results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.
- Conditions
- Anal Cancer
- Keywords
- anal cancer, Radiotherapy, Sexual dysfunction, Female sexual health, Gynecological side effects, Patient-reported outcomes
- Medical subject headings
- Anus Neoplasms, Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer
This outcome measures how many participants have moderate or severe narrowing of the vagina after treatment for anal cancer. Vaginal stenosis will be assessed during a gynaecological examination using a standard clinical grading system CTCAE v. 5.
Measured: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Secondary outcomes (5)
Gynecological findings at examination after radiotherapy for anal cancer
This outcome measures physical changes in the vagina assessed during a standardised gynaecological examination. Findings include vaginal stiffness, scarring, fragile tissue with bleeding, small visible blood vessels, ulcers, and adhesions. All findings are recorded using a structured electronic clinical examination form based on established vaginal morbidity assessment methods.
Measured: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Patient-reported sexual health and quality of life after radiotherapy for anal cance
Participants complete validated questionnaires covering sexual health and quality of life:
- EORTC QLQ-C30 and EORTC QLQ-ANL27 for general and anal cancer-specific quality of life
- EORTC QLQ-SH22 for sexual health, including vaginal dryness, pain, and sexual satisfaction
- Female Sexual Function Index (FSFI) for sexual desire, arousal, lubrication, orgasm, satisfaction, and pain
All questionnaires use fixed response scales and are scored according to official scoring manuals.
Measured: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy
This outcome measures how often participants use vaginal dilators, whether they use local or systemic hormone treatment, and whether they have received specialised sexual counselling after radiotherapy. Data are collected using a structured pattern-of-care questionnaire completed by participants.
Measured: Single questionnaire assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Radiation dose to the vagina and its relation to vaginal stenosis
This outcome measures the radiation dose received by the vagina during treatment and examines its relation to moderate or severe vaginal stenosis. The vagina is outlined retrospectively on radiotherapy planning scans, and dose-volume data are extracted from treatment plans. These dose data are analysed in relation to clinical findings of vaginal stenosis.
Measured: Retrospective analysis of radiotherapy plans after study inclusion
Patient satisfaction with guidance on gynecological and sexual side effects
This outcome measures how satisfied participants are with the information and support they received about vaginal and sexual side effects after radiotherapy. Data are collected through semi-structured telephone interviews, which explore timing, clarity, and usefulness of the guidance. Interview data are analysed using thematic analysis.
Measured: Single telephone interview within 3 months after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start13 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Oncology, Vejle Hospital, Department of Oncology Herlev Hospital, Denmark
- Responsible party
- Principal investigator, Johanne Hollands Steffensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296237
- Sponsor's protocol ID
- 1-10-72-19-25
- Other IDs
- 1-10-72-19-25
- Acronym
- DACG VI
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
- ClinicalTrials.gov ID
- NCT07296237
- Acronym / sponsor ID
- DACG VI / 1-10-72-19-25
- Conditions
- Anal Cancer
- Keywords
- anal cancer, Radiotherapy, Sexual dysfunction, Female sexual health, Gynecological side effects, Patient-reported outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Department of Oncology, Vejle Hospital, Department of Oncology Herlev Hospital, Denmark
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Dec 2025 (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.
The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems.
The main questions this study aims to answer are:
- How many women develop moderate or severe narrowing of the vagina after radiotherapy?
- Is there a link between the radiation dose and vaginal problems?
- How do vaginal changes affect sexual health and daily life?
- What care and support do women receive, and how satisfied are they with this support?
Participants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment.
Participants will:
Have a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment
The study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study.
The results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult women who have been treated with chemoradiotherapy for anal cancer in Denmark. Participants are recruited during routine follow-up visits at three oncology departments. All participants are between 6 and 36 months after treatment and are in cancer follow-up care
Key inclusion criteria (5 listed)
- Women aged 18 years or older
- Diagnosed with anal cancer
- Treated with chemoradiotherapy with curative intent
- Between 6 and 36 months since completion of radiotherapy
- Able and willing to give written informed consent
Key exclusion criteria (3 listed)
- Previous pelvic radiotherapy for another disease
- Treated with electron beam radiotherapy
- Unable to speak or understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer
Time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
This outcome measures how many participants have moderate or severe narrowing of the vagina after treatment for anal cancer. Vaginal stenosis will be assessed during a gynaecological examination using a standard clinical grading system CTCAE v. 5.
5 secondary outcomes
Gynecological findings at examination after radiotherapy for anal cancer
Time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Patient-reported sexual health and quality of life after radiotherapy for anal cance
Time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy
Time frame: Single questionnaire assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
Radiation dose to the vagina and its relation to vaginal stenosis
Time frame: Retrospective analysis of radiotherapy plans after study inclusion
Patient satisfaction with guidance on gynecological and sexual side effects
Time frame: Single telephone interview within 3 months after study inclusion
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 22 Dec 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Aarhus University Hospital at 3 sites in Denmark.
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 5 inclusion and 3 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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 Johanne H. Steffensen, MD. (004551434830, johste@oncology.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer (time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.