Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy: A Randomized, Double-blind, Sham-controlled Trial - LIGHT Study
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index (FSFI)
研究概览
简要总结
Background: Vulvovaginal health, directly linked to sexual health, is a key factor for female pleasure. BCS receiving AI are likely to present severe GSM and sexual complaints. Innovative options, as vaginal laser therapy, are emerging to treat GSM and sexual dysfunctions. Nowadays, data in BCS is scarce, moreover, few studies included patients receiving AI [16]. Different meta-analysis [17-23] found GSM [24, 25] and sexual function [9, 10] may improve significantly at short-term, however, the body of evidence is of low quality. Therefore, before recommendation of laser therapy for sexual complaints in BCS with GSM, there are unmet needs to be solved: efficacy and safety at long-term, biases related to patients' expectations and a detailed assessment of the complex underpinnings of sexuality.
Aims: To evaluate sexual and vaginal health in BCS receiving AI with GSM, before and after CO2 laser therapy compared to a sham-controlled group.
Methods: Prospective, randomized, double-blind controlled study with two parallel study arms: 1) Fractional CO2 laser therapy (5monthly sessions). 2) Sham laser therapy (5monthly sessions). After end-treatment, patients are followed up at 1 month and 6 months. BCS treated or undergoing AI with GSM and sexual function impairment, will be suitable. All patients will maintain first-line non-hormonal treatment and sexual assessment (PLISSIT Model) according with usual care. The primary outcome is improvement in sexual function (FSFI total score). As secondary outcomes: resumption sexual activity, sexual activity frequency, dyspareunia (VAS), female sexual dysfunction, sexual dimensions (FSFI), body image (S-BIS), quality of life (SF-12), vaginal pH acidification, maturation index and Vaginal Health Index of Gloria Backmann, adverse events, satisfaction (Likert scale) and adherence to treatment.
Expected impact: Emergent, non-invasive, laser therapy has significant benefit for BCS with AI, improving subjective and objective sexual and vaginal health outcomes and adding value to the usual care multidisciplinary approach.
详细描述
BACKGROUND:
Sexuality is a central aspect of being human throughout life encompasses sex, gender identities and roles, sexual orientation, eroticism, pleasure, intimacy and reproduction. Most of these aspects may be affected in breast cancer survivors (BCS). In a recent meta-analysis, focused on sexual function through Female Sexual Function Index (FSFI) among BCS, female sexual dysfunction prevalence was 73,4% (95 % CI 64-82.8 %, I2 = 96.8 %) and mean FSFI 19.28 (95 % CI 17.39-21.16, I2 = 97.6 %). Several modifiable risk factors for sexual dysfunction in BCS may be optimum targets for intervention: amelioration of vaginal discomfort and urinary incontinence, the benefits of breast conserving surgery on body image or the evaluation of relationship quality. Due to the multifaceted nature of the factors affecting sexuality in BCS, most authors encouraged the need for comprehensive assessment and for a multidisciplinary approach.
BC diagnosis and/or its treatments (surgery, chemoradiotherapy, hormonal therapy) may altered sexual health. Vulvovaginal health, directly linked to sexual health, is a key factor for female pleasure. Genitourinary syndrome of menopause (GSM) is caused by decline in estrogen at menopause, which may also appear or worsen after systemic cancer treatments as aromatase inhibitors (AI). GSM is associated with sexual symptoms (lack of lubrication, discomfort or pain, impaired function), genital symptoms (dryness, burning, irritation) and urinary symptoms (urgency, dysuria, recurrent urinary tract infections). BCS receiving AI are one of the groups most likely to present severe GSM and sexual complaints. A cross-sectional study on 129 BCS during the first 2 years of adjuvant AI therapy, found 3 out of 4 women were distressed about their sexual problems. Only 52% of women had been sexually active when endocrine therapy began, but 79% of that group developed new sexual problems.
The first line of treatment for GSM is non-hormonal therapy (regular sexual activity, moisturizers-lubricants, pelvic-floor relaxation techniques, dilators) although in many women these options will not adequately control symptoms. Hormonal therapies must be used with caution in women with estrogen-dependent cancers. So, alternative options are emerging for this subset of patients, such as vaginal laser therapy. Different studies provided short-term data on non-cancer patients that showed laser therapy was feasible, safe and improved objective and subjective GSM. Data regarding sexuality derived from secondary endpoints and suggested that laser therapy may improve sexual function, mainly decreasing sexual pain. To date, data on laser therapy in BCS is scarce, moreover, few studies included patients receiving ongoing AI. The CO2 laser was the most frequently used device. Different reviews and meta-analysis found GSM and sexual function may improve significantly at short-term, however, the body of evidence is of low quality. Therefore, before recommendation for the use of laser therapy for sexual complaints in BCS with GSM, there are unmet needs to be solved as efficacy and safety at long-term, biases related to patients' expectations of therapy and a detailed assessment of the complex underpinnings of sexuality.
AIMS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BC treated with aromatase inhibitors ± GnRH analogues (aGnRH)
- •Menopause (natural or induced) and signs / symptoms of GSM
- •Vaginal pH ≥5
- •Negative Human Papillomavirus (HPV) cytology and / or determination
- •Intention or willingness to have sex
- •Signed informed consent
排除标准
- •Vaginal hormonal treatment in the last 6 months
- •Vaginal moisturizers and / or lubricants during the 30 days prior to study treatment
- •Laser treatment, radiofrequency, hyaluronic acid, lipofilling in the vagina during the last 2 years
- •Ospemifene treatment
- •Being affected for: active infection of the genital tract; intraepithelial neoplasm of cervix, vagina, or vulva; have or have been treated for genital cancer
- •Genital prolapse stage ≥II.
结局指标
主要结局
Female Sexual Function Index (FSFI)
时间窗: 12 months
The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal; 0.3 for lubrication; 0.4 for orgasm; 0.4 for satisfaction; and 0.4 for pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score.
次要结局
- Dyspareunia(12 months)
- Sexual activity frequency(12 months)
- Body image perception(12 months)
- Vaginal epithelium thickness(12 months)
- Resumption of sexual activity(12 months)
- Female sexual dysfunction(12 months)
- Vaginal pH(12 months)
研究者
Inmaculada Alonso, MD, PhD
Principal Investigator, Clinical Professor
Hospital Clinic of Barcelona