Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Royal North Shore Hospital70 enrolled

Overview

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.

LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero) Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vulvovaginal Atrophy Genitourinary Symptoms and Ill-Defined Conditions

Interventions

CO2 Fractional Ablative LaserDEVICE

Vaginal / vulval laser treatment

PlaceboDEVICE

Sham Device

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

RECRUITING

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

RECRUITING

Outcomes

Primary Outcomes

Vaginal dryness

Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible.

Time frame: 12 weeks after completion of treatment

Secondary Outcomes

Other symptoms of vulvovaginal atrophy

Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)

Time frame: 12 weeks after completion of treatment and 12 months after active treatment

Maturation index

Improvement in maturation index from a vaginal swab (a pathological test: the maturation index counts 200 cells and compares the ratio of parabasal:intermediate:superficial squamous cells. Oestrogen deficient smears will show fewer superficial cells and an increase in parabasals (implies an atrophic picture) )

Time frame: 12 weeks after completion of treatment and 12 months after active treatment

Vaginal pH

Improvement in vaginal pH

Time frame: 12 weeks after completion of treatment and 12 months after active treatment

Clinician Assessed Changes

Improvement in vaginal moistness, colour and labia stickiness (moistness and stickiness assessed by a physician as present or not, colour as assessed on a predefined colour chart out of 4 colours).

Time frame: 12 weeks after completion of treatment and 12 months after active treatment

Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index

Improvement in QOL assessed on the Vulval Quality of Life Index (VQLI) -a validated tool. The scoring bands of the VQLI includes: 0-5 = no effect on patient's life, 6-13 = small effect on patient's life, 14-23 = moderate effect on patient's life, 24-37 = very large effect on patient's life, 38-45 = extremely large effect on patient's life.

Central Contacts

Antonia Pearson, BMed

CONTACT

+61402308664 antonia.pearson@sydney.edu.au

Emily Forward, MBBS MBA BSc

CONTACT

+61 2 9462 9657 eforward.derm@gmail.com

Data from ClinicalTrials.gov

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