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

Sponsor
Aarhus University Hospital
Study ID
NCT07296237
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Dec 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
80 participants (estimated)

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 ]

Central Contacts

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