Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer (DACG VI)

December 9, 2025 updated by: Johanne Hollands Steffensen, Aarhus University Hospital

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:

  • 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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Department of Oncology Aarhus University Hospital (AUH)
        • Contact:
      • Herlev, Denmark, 2730
        • Recruiting
        • Department of Oncology, Herlev and Gentofte Hospital
        • Contact:
      • Vejle, Denmark, 7100
        • Recruiting
        • Department of Oncology Vejle Hospital, University Hospital of Southern Denmark
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous pelvic radiotherapy for another disease
  • Treated with electron beam radiotherapy
  • Unable to speak or understand Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gynecological findings at examination after radiotherapy for anal cancer
Time Frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
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.
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

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.
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
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.
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
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.
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
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.
Single telephone interview within 3 months after study inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Department of Oncology Herlev Hospital, Denmark
Department of Oncology, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-19-25 (Other Identifier: The Regional Ethics Committee for the Central Denmark Region)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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