Clinical trial NCT06007027: Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
Official title: Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: laser
mamma cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Vaginal dryness
timeFrame: Symptom data is collected at baseline visit and one month after the last treatment
Secondary outcomes:
measure: Change in vaginal pain, itching and soreness
timeFrame: Symptom data is collected at baseline visit and one month after the last treatment
measure: Female Sexual Function Index
timeFrame: Symptom data is collected at baseline visit and one month after the last treatment
measure: Sexual complaint screener - women
timeFrame: Symptom data is collected at baseline visit and one month after the last treatment
measure: Urogenital Distress Inventory
timeFrame: Symptom data is collected at baseline visit and one month after the last treatment
measure: International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex
timeFrame: Symptom data is collected at baseline visit and one month after the last treatment
measure: Vaginal health index
timeFrame: Vaginal health index is evaluated at baseline visit and one month after the last treatment
measure: Vaginal biopsy
timeFrame: Vaginal biopsy is collected at baseline visit and one month after the last treatment
measure: Vaginal and urinary microbiota
timeFrame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Department of Obstetrics and Gynaecology, Randers Regional Hospital
Study officials:
References: