Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients (LAAVA2)

March 10, 2020 updated by: Royal North Shore Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonia Pearson, BMed FRACP
        • Principal Investigator:
          • Emily Forward, MBBS MBA Bsc
        • Principal Investigator:
          • Gail Fischer, OAM FACD MD
        • Sub-Investigator:
          • Sally Baron-Hay, MBBS FRACP
      • Wahroonga, New South Wales, Australia, 2074
        • Recruiting
        • Sydney Adventist Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gavin Marx, MBBS FRACP
        • Principal Investigator:
          • Andrew Booker, BMedFRANZCOG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CO2 Fractional Ablative Laser
3 treatments approximately 4 weeks apart with vaginal/vulval laser
Device: CO2 Fractional Ablative Laser
Vaginal / vulval laser treatment
Other Names:
  • Monalisa Touch
  • Lotus
Placebo Comparator: Placebo
3 treatments approximately 4 weeks apart with "sham" laser
Device: Placebo
Sham Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal dryness
Time Frame: 12 weeks after completion of treatment
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.
12 weeks after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other symptoms of vulvovaginal atrophy
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment
Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)
12 weeks after completion of treatment and 12 months after active treatment
Maturation index
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment

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)

)
12 weeks after completion of treatment and 12 months after active treatment
Vaginal pH
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment
Improvement in vaginal pH
12 weeks after completion of treatment and 12 months after active treatment
Clinician Assessed Changes
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment
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).
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
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment
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.
12 weeks after completion of treatment and 12 months after active treatment
Sexual Function
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment
Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool
12 weeks after completion of treatment and 12 months after active treatment
Satisfaction with treatment assessed on a Likert Scale
Time Frame: 12 weeks after completion of treatment and 12 months after active treatment
Patient satisfaction assessed on Likert Scale - a validated tool scoring from 1 to 5 (1=strongly disagree, 2=disagree, 3= neutral, 4=agree, 5=strongly agree)
12 weeks after completion of treatment and 12 months after active treatment
Safety of laser treatment (Side effects)
Time Frame: 15 months
Side effects reported over the duration of the study will be collected descriptively
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal North Shore Hospital

Investigators

  • Principal Investigator: Antonia Pearson, BMed, Royal North Shore Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAAVA2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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