Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1-10-72-19-25 | Other Identifier | The Regional Ethics Committee for the Central Denmark Region |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Department of Oncology, Vejle Hospital | UNKNOWN |
| Department of Oncology Herlev Hospital, Denmark | UNKNOWN |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanne H. Steffensen, MD. | Contact | 004551434830 | johste@oncology.au.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology Aarhus University Hospital (AUH) | Recruiting | Aarhus | 8200 | Denmark |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2025 | Dec 9, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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:
All questionnaires use fixed response scales and are scored according to official scoring manuals. | 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. | 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. | 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. | Single telephone interview within 3 months after study inclusion |
| Department of Oncology, Herlev and Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
|
| Department of Oncology Vejle Hospital, University Hospital of Southern Denmark | Recruiting | Vejle | 7100 | Denmark |
|
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |