Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

  • STATUS
    Recruiting
  • End date
    Oct 1, 2021
  • participants needed
    70
  • sponsor
    Royal North Shore Hospital
Updated on 16 March 2020
Investigator
Antonia Pearson, BMed FRACP
Primary Contact
Royal North Shore Hospital (4.8 mi away) Contact
+1 other location

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.

Description

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.

Details
Treatment Placebo, CO2 Fractional Ablative Laser
Clinical Study IdentifierNCT03628092
SponsorRoyal North Shore Hospital
Last Modified on16 March 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Vulvovaginal Atrophy or Genitourinary Symptoms and Ill-Defined Conditions?
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)
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