Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Vaginal dryness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Vaginal dryness
时间窗: 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.
次要结局
- 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)
- Other symptoms of vulvovaginal atrophy(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)
- Sexual Function(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)
- Satisfaction with treatment assessed on a Likert Scale(12 weeks after completion of treatment and 12 months after active treatment)
- Safety of laser treatment (Side effects)(15 months)