RecruitingNot ApplicableNCT06007027

Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study

Sponsor

University of Aarhus

Enrollment

60 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Genitourinary Syndrome of Menopause

Summary

This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vaginal CO2 laser therapy can relieve vaginal dryness, pain during sex, and other discomforts (called genitourinary syndrome of menopause) in breast cancer survivors who are taking endocrine (hormone-blocking) therapy. **You may be eligible if:** - You are a breast cancer survivor currently on endocrine therapy (e.g., tamoxifen or an aromatase inhibitor) - You have vaginal discomfort or pain during sex related to menopause symptoms - You can read and understand Danish **You may NOT be eligible if:** - You have significant pelvic organ prolapse (stage 2 or higher) - You have used vaginal treatments (hormonal or non-hormonal) recently (within 1–12 months) - You had chemotherapy within the past 6 months - You have an active urinary tract infection or genital infection - You have had vaginal reconstructive surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Locations(1)

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, Denmark

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NCT06007027

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