Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Efficacy of the film-forming solution Evonail® versus placebo on nail damage
研究概览
简要总结
Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.
Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.
The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Age ≥ 18 years old
- •Patient with breast carcinoma
- •Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®)
- •Patients who have never been treated with taxanes
- •Patients with no nail damage before starting the study
- •ECOG performance < 2
- •Ability to provide written informed consent
排除标准
- •Patient allergic to any of the treatment components
- •Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment
- •Risk of exposure to aggressive factors nail during the study
- •Using refrigerants gloves during chemotherapy treatments
- •Onychophagia
- •Presence of nail disease or a history of nail pathology (infectious and other)
- •Pregnant or breast feeding females
- •Patients whose condition is not compatible with the follow-up study
结局指标
主要结局
Efficacy of the film-forming solution Evonail® versus placebo on nail damage
时间窗: up to 9 weeks
Efficacy will be evaluated by the oncologist according to NCI-CTC
次要结局
- Patient compliance for the film-forming solution Evonail®(up to 9 weeks)
- Different types of nail damage observed in each group after chemotherapy docetaxel(up to 9 weeks)
- Patient satisfaction regarding the use of the film-forming solution Evonail®(up to 9 weeks)