Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Overall patient satisfaction after 30 days treatment
研究概览
简要总结
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary
详细描述
The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer).
Although having a much better tolerance profile than the "classical" cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia).
The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment.
Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity.
In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity.
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
- 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
- •Age ≥ 18 years.
- •Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations.
- •Treated for the first time by an iEGFR having received a marketing authorization.
- •Having signed a consent to participate in the study.
- •Affiliated to a health insurance plan (or beneficiary of such a plan).
排除标准
- •Concomitant radiotherapy.
- •Unresolved skin toxicity from previous treatment, whatever it may be.
- •Concomitant use of other topical treatments.
- •Known hypersensitivity to at least one of the components of the topicals used.
- •Pregnant or lactating women.
- •Participation in another clinical trial (even if supportive care)
结局指标
主要结局
Overall patient satisfaction after 30 days treatment
时间窗: After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days
Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm
次要结局
- Cutaneous toxicities evaluation using Common Terminology Criteria for Adverse Events (CTCAE) version 4(After 15, 30 and 60 days of treatment)
- DLQI and SCOREPI scores correlation(After 30 and 60 days of treatment)
- Topical observance(Between the 1st day and the 15th day of treatment, and between the 15th and the 30th day of treatment)
- Use rate of dermocorticoids(Continously up to 60 days after starting treatment)
- Patient Quality of life(At inclusion, after 30 and 60 days of treatment)
- Cutaneous toxicities evaluation using Epidermal Repair Score (SCOREPI)(After 15, 30 and 60 days of treatment)
- Modification/Interruption/Discontinuing iEGFR treatment rate(Continuously up to 30 days after starting treatment)
- Overall patient satisfaction after 60 days treatment(After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days)