RecruitingNAINTERVENTIONAL

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

This research trial is for women with anal cancer who are having radiotherapy. Radiotherapy can sometimes cause the vagina to narrow, also known as vaginal stenosis, which can be uncomfortable. This study aims to find out if using a slightly larger tampon (28mm) during each radiotherapy session can help prevent this narrowing more effectively than a standard one (12-13mm). Researchers believe this approach might reduce the chance of serious vaginal narrowing from 50% to 25% or less. They will compare two groups of patients: one using the special tampon and another using a standard tampon. The main goal is to see how much vaginal narrowing occurs 12 months after radiotherapy and how this affects patients' comfort and quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Juergen Debus

Enrolment target

Start

01 Oct 2019

Estimated completion

01 Apr 2027

Anal Cancer

What is this study about?

When women have radiotherapy for anal cancer, the treatment can sometimes cause changes to the vagina. One of these changes is a condition called vaginal stenosis, which means the vagina can become narrower, shorter, or less flexible. This can cause discomfort, pain, or make activities like sexual intercourse difficult. Doctors try to find ways to prevent or reduce these side effects to help women have a better quality of life after their cancer treatment.

This study is testing a simple way to try and prevent this narrowing. They are looking at whether using a small device, like a tampon, inside the vagina during each radiotherapy session can help. The idea is that gently stretching the vagina during treatment might help keep it more open afterwards. The study wants to see if a slightly larger tampon (28mm) works better at preventing narrowing compared to a standard-sized one (12-13mm).

Sixty women will take part in this study. Half will use the slightly larger tampon, and the other half will use the standard tampon. Both groups will receive the same standard radiotherapy and chemotherapy (if needed) for their anal cancer. The doctors will then check 12 months after treatment to see how much, if any, vaginal narrowing has occurred in each group, and how this has affected their daily lives and comfort.

Key takeaways

This study evaluates whether a larger tampon used during radiotherapy can prevent vaginal narrowing.
It aims to improve comfort and quality of life for women after anal cancer treatment.
Participation involves using a specific tampon size during each radiotherapy session.
Researchers will compare results from women using a standard tampon versus a larger one.
The main outcome is to assess vaginal narrowing 12 months after treatment.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for women who have anal cancer that has been confirmed by a doctor, and who are going to have radiotherapy as part of their treatment. You need to be 18 years old or older to take part. Also, you should be generally well enough to go about your daily activities with little to no difficulty.

There are some reasons why you might not be able to join. For example, if you've already had radiotherapy in the same area of your body, or if you're already taking part in another clinical trial that might affect the results of this one. You also can't participate if you're pregnant, breastfeeding, or unable to use contraception if you could become pregnant.

It's also important that doctors are able to comfortably fit a dilator (like a tampon) inside your vagina before your radiotherapy treatment begins. If this isn't possible, you wouldn't be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman diagnosed with anal cancer?
Are you going to have radiotherapy for your anal cancer?
Are you 18 years old or older?
Is your general health reasonably good (ECOG 0-2)?
Can a doctor comfortably examine your vagina with a dilator before radiotherapy starts?
Are you not pregnant or breastfeeding, and using reliable contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly put into one of two groups. This is like flipping a coin, so it's fair – you won't get to choose which group you're in. Both groups will receive the standard radiotherapy for anal cancer. The only difference is the size of the tampon you'll be asked to use during each radiotherapy session.

During your radiotherapy treatment, you will insert either a standard-sized tampon (12-13mm diameter) or a special larger tampon (28mm diameter) into your vagina. The study is checking if the larger tampon helps more. You will need to use this tampon during each radiotherapy session. Doctors will also check your vagina regularly to measure how well the treatment is working and look for any side effects. You'll also be asked to complete some questionnaires about your quality of life and any symptoms you might have. The main follow-up to check for vaginal narrowing will be 12 months after your radiotherapy ends. This study is designed to assess your comfort during the daily use of the tampon/dilator as well as your feedback on daily use and side effects will also be monitored.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that if the larger tampon proves effective, it could help reduce the chance of vaginal narrowing after radiotherapy, which might improve your comfort and quality of life. However, it's also possible that there's no difference between the two tampon sizes, or that using the larger tampon could cause some temporary discomfort. All medical treatments have potential side effects, and your doctors will discuss these with you. You are free to stop participating in the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

University Hospital of Heidelberg, Radiation Oncology
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is vaginal stenosis?

Vaginal stenosis is when the vagina becomes narrower, shorter, or less flexible, often due to radiotherapy treatment in the pelvic area.

What is a 'vaginal dilator'?

A vaginal dilator is a smooth, medical device, often shaped like a tampon, used to gently stretch and maintain the flexibility of the vagina.

Why use a tampon during radiotherapy?

Using a tampon or similar device during radiotherapy is thought to help keep the vagina stretched open a little, potentially preventing it from narrowing after treatment.

Will I know which tampon size I'm using?

Yes, you will be told which tampon size you are assigned to as part of your treatment plan.

What happens after the study ends?

After the study, your medical care will continue as normal. The results of the study will be used to help improve care for future patients.

How to find out more

Nathalie Arians, MD

nathalie.arians@med.uni-heidleberg.de +49 6221 568202 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.