Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Vulvovaginal Atrophy Clinical Trial

— LAAVA2  

Official title:

Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03628092
• Other study ID #: LAAVA2
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2020
• Source: Royal North Shore Hospital
• Contact: Antonia Pearson, BMed
• Phone: +61402308664
• Email: antonia.pearson[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Genitourinary Symptoms and Ill-Defined Conditions
• Vulvovaginal Atrophy

Intervention

Device:
• CO2 Fractional Ablative Laser
Vaginal / vulval laser treatment
• Placebo
Sham Device

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Sydney Adventist Hospital	Wahroonga	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other symptoms of vulvovaginal atrophy	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
Secondary	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); )	12 weeks after completion of treatment and 12 months after active treatment
Secondary	Vaginal pH	Improvement in vaginal pH	12 weeks after completion of treatment and 12 months after active treatment
Secondary	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).	12 weeks after completion of treatment and 12 months after active treatment
Secondary	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.	12 weeks after completion of treatment and 12 months after active treatment
Secondary	Sexual Function	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
Secondary	Satisfaction with treatment assessed on a Likert Scale	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
Secondary	Safety of laser treatment (Side effects)	Side effects reported over the duration of the study will be collected descriptively	15 months