A Randomized Phase II Study to Explore the Benefits of the MonaLisa Touch® System in the Improvement of the Sexual QUAlity of Life in Gynaecological Cancer Patients Treated by (Chemo)-Radiotherapy.(SQUAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Variations of the sexual function through FSFI questionnaire
研究概览
简要总结
The increasing survival rate of gynaecological cancer patients highlights the need to improve their Quality of Life (QoL) after treatment. Among all QoL factors, sexuality is unfortunately often neglected, especially vaginal dryness and fibrosis/stenosis. Currently, the latter is standardly treated by vaginal dilators, which may induce pain and discomfort (1). A new possibility, already used in some centers, is the MonaLisa Touch® system, a microablative CO2 laser (2). Its efficiency to improve sexual QoL has already been demonstrated in breast cancer patients treated with chemotherapy and/or hormonotherapy and in menopausal women (3). Unfortunately, almost no study have been conducted yet for patients undergoing radiotherapy to the pelvic area to prevent vaginal morbidity. Our randomised study will explore the benefits of the MonaLisa Touch® device for the prevention of sexual adverse events induced by pelvic (chemo-) radiotherapy for pelvic cancers.
详细描述
Patients will be randomly (1:1) assigned to the dilators (standard of care) or MonaLisa Touch® system (2 arms). Patients will be stratified for endometrial or cervix cancer, radiotherapy dose and techniques, menopausal status, tumor stage, chemotherapy or not, surgery or not. Patients will begin the Mona Lisa at 3 months, once per month during 6 months while the follow-up assessment will continue until 12M after end of RT treatment. Patients randomized in dilator arm will also begin 3 months post end of RT and will use them twice every 2 weeks for 12M (as standard of care).
Questionnaires (FSFI- Female Sexual Function Index [10], SHQ-22) and VHI (Vaginal Health Index [11]) will be performed before treatment, at 3, 6, 9, 12 and 15M. Partners will also be asked to fill the sexual quality of life questionnaire EORTC SHQ-22 before and after treatment.
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
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(chemo)radiotherapy +/- brachytherapy, gynaecologic cancer patients
- •complete response on the imagery at 3 months (PET scan/MRI).
- •Stades I-III
排除标准
- •No complete response under imagery at 3months
- •Relapse of gynaecological cancer
- •Active gynaecological infection
- •Pelvic organ prolapse more than stage II
- •Local vaginal hormone therapy within 6 weeks prior to enrolment
结局指标
主要结局
Variations of the sexual function through FSFI questionnaire
时间窗: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Sexual QOL questionnaire
Variations of the sexual function through SHQ-22 questionnaire
时间窗: before (chemo-RT) to 15 months post (Chemo)-RT treatment
Sexual QOL questionnaire
次要结局
- Vaginal functional changes by means of VHI score(3 months to 15 months post (Chemo)-RT treatment)
- Patient complience(3 months to 15 months post (Chemo)-RT treatment)
研究者
Clémence Al Wardi
Pr
Jules Bordet Institute