Clinical trial · Observational
Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of moderate to severe vaginal stenosis after radiotherapy for anal cancer
- timeFrame
- Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
- description
- 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 (5)
- measure
- Gynecological findings at examination after radiotherapy for anal cancer
- timeFrame
- Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available