Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Compare the grade of the patient alopecia.
研究概览
简要总结
The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy.
This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of localised, non-metastatic breast cancer
- •Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 or 4 EC100 followed by 3 Docetaxel or 3 or 4 EC100 plus 9 to 12 Paclitaxel); HER-positive status is not a non-inclusion criterion.
- •Patient willing to be photographed to assess IFA
- •Fluency in French
- •Patient affiliated to a social security scheme
- •Signature of informed consent
排除标准
- •History of neck pain
- •Pre-existing alopecia
- •Participation in another trial
- •Dermatosis of the scalp
- •Contraindication to scalp cooling
- •History of migraines, stroke or hyperthyroidism
- •History of scalp metastases
- •Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia or post-traumatic cold dystrophy.
- •Malignant haemopathies
- •History of chemotherapy treatment
- •Indication for cerebral irradiation
- •Pregnant or breast-feeding patient
- •Raynaud's syndrome
研究组 & 干预措施
standard cold-cap
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
This device will be supplemented by a compression bandage to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the effectiveness of the device.
干预措施: standard cold cap (Other)
scalp-cooling technique
Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
干预措施: scalp-cooling technique (Other)
结局指标
主要结局
Compare the grade of the patient alopecia.
时间窗: At 6 months after treatment start
The grade of patient alopecia will be be evaluated by NCI-CTCAE
次要结局
未报告次要终点