Comparing laser treatment and hyaluronic acid for menopause symptoms in breast cancer survivors
Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)
This study is testing whether laser treatment or a hyaluronic acid suppository can help women who are breast cancer survivors and are dealing with menopause symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT03816735 on ClinicalTrials.gov |
What this trial studies
This clinical trial invites women with a history of breast cancer experiencing genitourinary symptoms of menopause to participate. Participants will be randomly assigned to receive either intravaginal laser treatment or hyaluronic acid suppository therapy. The laser treatment will occur twice, while the suppository will be applied daily for the first 10 days and then every third day for three months. Patient-reported outcomes will be assessed using various questionnaires at baseline and after three months to evaluate the effectiveness of each treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-80 with a history of breast cancer who experience symptoms such as dryness, burning, or discomfort during sexual intercourse.
Not a fit: Patients with current or past genitourinary malignancies or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for breast cancer survivors suffering from menopause-related symptoms.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of laser versus hyaluronic acid is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * genital symptoms of dryness/ burning/ irritation * and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain * and/or symptoms of urgency and dysuria or recurrent urinary tract infection * Age 18-80 * History of BC and/ or DCIS * Completed locoregional therapy * Current antihormonal therapy for BC possible * Intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial Exclusion criteria: * Current or past genitourinary malignancy * Abnormal PAP smear * Current genitourinary tract infection * Abnormal uterine bleeding * photosensitive medication
Where this trial is running
Graz
- Department of Obstetrics, Medical University Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Daniela Gold, MD PhD
- Email: daniela.gold@medunigraz.at
- Phone: 004331638512201
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.