Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
This study explores a treatment called vaginal radiofrequency for managing vaginal dryness in women who have breast cancer and are taking hormone therapy. Vaginal dryness can be a challenging side effect of these treatments. The research aims to see if vaginal radiofrequency, which uses gentle heat, can improve symptoms more than using a non-hormonal vaginal moisturiser alone. Participants will be split into two groups: one receiving the moisturiser, and the other receiving the moisturiser plus three sessions of radiofrequency treatment. The study will track progress over six months to see how effective the radiofrequency treatment is.
At a glance
What is this study about?
This study is looking into a common but often unmentioned problem many women face after breast cancer treatment: vaginal dryness. When you're having hormone therapy for breast cancer, such as with certain medications called aromatase inhibitors, these treatments can sometimes cause your body to produce less oestrogen. This can lead to your vaginal tissues becoming thinner, drier, and less elastic, which doctors call vulvovaginal atrophy. It can cause discomfort, pain during sex, and sometimes affect your quality of life.
Currently, many women use non-hormonal moisturisers to help with these symptoms. This study wants to see if a newer treatment, called vaginal radiofrequency, can offer more relief. Vaginal radiofrequency is a treatment that uses gentle heat to stimulate the tissues in the vagina. The idea is that this heat might help improve the health and moisture of the vaginal walls.
The researchers want to compare this radiofrequency treatment with the standard non-hormonal moisturiser to understand if it adds extra benefits for women in this situation. They will look at whether it can make a real difference to the symptoms of vaginal dryness over a six-month period.
Key takeaways
- This study evaluates a new treatment for vaginal dryness in breast cancer patients.
- It compares vaginal radiofrequency with standard moisturiser treatment.
- Participation involves either regular moisturiser use or moisturiser plus radiofrequency sessions.
- The study lasts for six months.
- It aims to improve comfort for women experiencing vaginal dryness due to breast cancer treatment.
Who may be eligible?
You might be able to take part in this study if you are a woman over 40 years old and are experiencing troublesome vaginal dryness, even though you've already been using a local vaginal moisturiser.
You also need to be receiving treatment for breast cancer with certain hormone therapies (like aromatase inhibitors, sometimes with LHRH agonists) and have at least 12 months of this treatment planned. It's important that you are signed up with a social security organisation and are willing to give your informed consent to join the study.
However, there are reasons why you might not be able to join. For example, if you have certain medical conditions like an ongoing urinary infection, a pacemaker, or an IUD. You also can't take part if you are pregnant or breastfeeding, or if you have specific skin conditions affecting the vaginal area. The study also can't include you if you've had other similar physical treatments for vaginal dryness in the last year, like vaginal laser therapy.
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 over 40 years old?
- Do you experience significant vaginal dryness despite using moisturisers?
- Are you currently receiving specific hormone therapy for breast cancer, with at least 12 months left?
- Do you NOT have a pacemaker, IUD, or ongoing urinary infection?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you decide to take part, you'll be randomly put into one of two groups. One group will use a non-hormonal vaginal moisturiser (containing hyaluronic acid) three times a week. The study team might also suggest other helpful things like pelvic floor exercises or vaginal dilators if they think it's right for you. The second group will use the same moisturiser but will also receive three sessions of vaginal radiofrequency treatment, with each session taking place about 4 to 6 weeks apart. The study will last for six months, during which time your symptoms will be monitored and compared between the two groups. You'll have regular check-ups with the study team during this period.
Potential risks and benefits
Locations (1)
- Centre Oscar LambretVerified postcodeLille, France· Recruiting
Common questions
What is vaginal dryness?
Vaginal dryness happens when the tissues in the vagina become thinner and less elastic, often due to lower hormone levels. It can cause discomfort, itching, and pain.
What is vaginal radiofrequency?
It's a treatment that uses gentle heat to stimulate the tissues in the vagina, aiming to improve their health and moisture.
Why is this study important for breast cancer patients?
Hormone therapy for breast cancer can cause vaginal dryness, and this study aims to find better ways to help manage these symptoms for patients.
Will I know which treatment I'm receiving?
No, you will be randomly assigned to one of two groups, and you won't choose which treatment you get. This helps ensure the study results are fair.
What if I decide I don't want to continue the study?
You are free to leave the study at any time, for any reason. Your decision will not affect your regular medical care.
How to find out more
Fanny BEN OUNE
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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