Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients (NCT03628092) | Clinical Trial Compass
UnknownNot Applicable
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Australia70 participantsStarted 2018-07-24
Plain-language summary
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Women with a history of early breast cancer \>18 years of age
* At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.
* Three groups of patients will qualify:
* Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \>6 months
* Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor
* Postmenopausal women on tamoxifen or an aromatase inhibitor
* Willingness to give written informed consent and willingness to comply with the study
* Up to date pap test / HPV (human papillomavirus) testing
Exclusion Criteria:
* Medical contraindication to the use of fractional ablative CO2 laser
* Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment
* Use of vaginal lubricants or moisturisers 14 days prior to the study treatment
* Active or recent genitourinary infections (\<30 days)
* Genital prolapse (grade III)
* Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts)
* Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)