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

NCT07296237 | Recruiting

• 1 other identifier: 1-10-72-19-25
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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

Anal Cancer

Keywords

anal cancer; Radiotherapy; Sexual dysfunction; Female sexual health; Gynecological side effects; Patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy

Secondary Outcomes (5)

• Gynecological findings at examination after radiotherapy for anal cancer

  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

  Single assessment at study visit, 6 to 36 months after completion of chemoradiotherapy

• Use of vaginal dilators, hormone treatment, and sexual counselling after radiotherapy

  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

  Retrospective analysis of radiotherapy plans after study inclusion

• Patient satisfaction with guidance on gynecological and sexual side effects

  Single telephone interview within 3 months after study inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Department of Oncology, Vejle Hospital: collaborator
• Department of Oncology Herlev Hospital, Denmark: collaborator

Study Sites (3)

Department of Oncology Aarhus University Hospital (AUH)

Aarhus, 8200, Denmark

RECRUITING

Department of Oncology, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Department of Oncology Vejle Hospital, University Hospital of Southern Denmark

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Johanne H. Steffensen, MD.

CONTACT

004551434830; johste@oncology.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

DK (3)