Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

NCT03628092 | Unknown

• 1 other identifier: LAAVA2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vulvovaginal Atrophy; Genitourinary Symptoms and Ill-Defined Conditions

Keywords

genitourinary symptoms of menopause; CO2 fractional ablative laser; Early breast cancer; Vulvovaginal atrophy; Vaginal dryness; Dyspareunia; Vaginal itch; Dysuria

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after completion of treatment

Secondary Outcomes (8)

• Other symptoms of vulvovaginal atrophy

  12 weeks after completion of treatment and 12 months after active treatment

• Maturation index

  12 weeks after completion of treatment and 12 months after active treatment

• Vaginal pH

  12 weeks after completion of treatment and 12 months after active treatment

• Clinician Assessed Changes

  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

  12 weeks after completion of treatment and 12 months after active treatment

Study Arms (2)

CO2 Fractional Ablative Laser

ACTIVE COMPARATOR

3 treatments approximately 4 weeks apart with vaginal/vulval laser

Device: CO2 Fractional Ablative Laser

Placebo

PLACEBO COMPARATOR

3 treatments approximately 4 weeks apart with "sham" laser

Device: Placebo

Interventions

CO2 Fractional Ablative Laser DEVICE

Vaginal / vulval laser treatment

Also known as: Monalisa Touch, Lotus

CO2 Fractional Ablative Laser

Placebo DEVICE

Sham Device

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (2)

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

Sydney Adventist Hospital

Wahroonga, New South Wales, 2074, Australia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Dyspareunia; Dysuria

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonia Pearson, BMed

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 14, 2018
• Study Start: July 24, 2018
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2021
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

AU (2)