Laser therapy for vaginal symptoms in breast cancer survivors
Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
This study is testing whether laser therapy can help breast cancer survivors who have vaginal symptoms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Randers) |
| Trial ID | NCT06007027 on ClinicalTrials.gov |
What this trial studies
This project involves three studies over three years focusing on breast cancer survivors experiencing genitourinary syndrome. The first study assesses the dose response of laser treatments in 30 participants, followed by a double-blind randomized controlled trial with 60 participants to compare active laser treatment against a placebo. The final study includes a one-year follow-up to evaluate the long-term effects of the treatment. Assessments will include questionnaires, vaginal fluid pH, biopsies, and microbiome analysis.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors currently on endocrine therapy who experience vaginal discomfort or dyspareunia.
Not a fit: Patients with pelvic organ prolapse stage 2 or higher, recent use of vaginal therapies, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate vaginal discomfort and improve quality of life for breast cancer survivors.
How similar studies have performed: While there is limited data on this specific approach, similar laser therapies have shown promise in treating genitourinary symptoms in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast cancer survivor in endocrine therapy * Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia * Able to read and understand Danish * Able to give written informed consent Exclusion Criteria: * Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system * Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively) * Use of Chemotherapy (6 months prior to the baseline visit) * Acute urinary tract infection or active genital infection * History of vaginal reconstructive surgery
Where this trial is running
Randers
- Department of Obstetrics and Gynaecology, Randers Regional Hospital — Randers, Denmark (Recruiting)
Study contacts
- Study coordinator: Sine Jacobsen, MD
- Email: sinjac@rm.dk
- Phone: +4578421069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.