An observational study in Anal Cancer, sponsored by Aarhus University Hospital. Recruiting at 3 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Aarhus University Hospital · Observational
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:
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.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 80 is below the median of 144 across 75 observational studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: Single telephone interview within 3 months after study inclusion
Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 9 months after the start.
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