NCT04402606已完成不适用
DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.
研究概览
简要总结
The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged 18 years and older, with a solid tumor breast or lung, localized, locally advanced or not, metastatic or not;
- •Patient in medical oncology consultation requiring systemic anti-tumor therapy (chemotherapy, targeted therapy, hormone therapy, immunotherapy) in neo-adjuvant, adjuvant or metastatic;
- •Treatment planned for a minimum period of 3 months (from the date of inclusion);
- •Having a social security protection;
- •Signed informed consent form of the study.
排除标准
- •Patient treated for lymphoma, leukemia or inflammatory breast cancer ;
- •Patient with a solid tumour which location is other than breast or lung;
- •Patient with a tumor wound ;
- •Patient with a general condition > 2 at baseline (ECOG classification) ;
- •Patient receiving anti-tumor treatment with radiotherapy exclusively or associated with concomitant radiotherapy ;
- •Patient unable to receive information about the study and to give consent ;
- •Persons deprived of liberty or guardianship ;
- •Impossible submission to study procedures for geographical or psychological reasons.
结局指标
主要结局
Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.
时间窗: 8 months
Severity of cutaneous toxicities at 8 months after the start of treatment (grade \> 2 according to the NCI-CTCAE classification version 4.03), induced by the anticancer treatments.
次要结局
- Define patient profiles likely to develop severe cutaneous toxicity during their anticancer treatment;(8 months)
- Evaluate variation rate of skin hydration over the course of the study(8 months)
- Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities(8 months)
- Evaluate variation rate of thickness, firmness, tone, viscosity of the skin over the course of the study(8 months)
- Evaluate variation rate of skin color over the course of the study(8 months)
- Evaluate variation rate of skin sebum quantity over the course of the study(8 months)
- Evaluate the temperature in case of skin toxicities(8 months)
- Evaluate skin elasticity index in case of toxicities(8 months)
- Evaluate variation rate of skin pH over the course of the study(8 months)
- Evaluate variation rate of skin temperature over the course of the study(8 months)
- Evaluate variation rate of insensitive loss of water of the skin over the course of the study(8 months)
- Evaluate skin color in case of skin toxicities(8 months)
- Evaluate the quantity of sebum in case of toxicities(8 months)
- Evaluate variation rate of skin elasticity over the course of the study(8 months)
- Evaluate plantar supports in case of toxicities(8 months)
- Evaluate Skin hydration rate in case of skin toxicities(8 months)
- Evaluate variation rate of plantar supports over the course of the study(8 months)
- To evaluate the quality of life of patients at 8 months;(8 months)
- Evaluate the skin pH in case of skin toxicities(8 months)
- Evaluate insensitive loss of water in case of toxicities(8 months)
- Evaluate the consequences of cutaneous toxicities on the patient's therapeutic scheme (hold, dosage reduction, change of molecule);(8 months)
研究者
研究点 (2)
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