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NCT Number: NCT07296237

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.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Oncology Aarhus University Hospital (AUH), Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne H. Steffensen, MD.

CONTACT

[email protected]

004551434830

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DACG VI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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