Evaluation of Novel Skin Care Products for the Management of Immunotherapy- Related Dermatologic Toxicities
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient benefit composite
研究概览
简要总结
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new immunomodulatory agents. The immunotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival.
Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the ImmunoSkin project, two novel skin care products to tackle the cutaneous adverse events of immunotherapy have been developed.
The ImmunoSkin project general aim is to evaluate the efficacy of two novel skincare products to manage immunotherapy-related cutaneous toxicities.
详细描述
Primary objective Evaluate the efficacy of two novel skin care products for the management of immunotherapy-related cutaneous adverse events
Secondary objective 1 Evaluate patient-relevant treatment benefit of two novel skin care products for immunotherapy-related cutaneous toxicities
Secondary objective 2 Evaluate the influence of two novel skin care products for immunotherapy-related cutaneous toxicities on the patient's quality of life
Secondary objective 3 Evaluate the safety of two novel skin care products for immunotherapy-related cutaneous toxicities
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
- •Diagnosed with cancer of any type
- •Undergoing immunotherapy, check point inhibitors, at the Jessa Hospital (Hasselt, BE)
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
排除标准
- •Pre-existing skin rash, ulceration, skin infections or open wounds
- •Severe psychological disorder or dementia
- •Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
结局指标
主要结局
Patient benefit composite
时间窗: Week 3 of immunotherapy (end of study)
Patient Benefit Index is a standardized questionnaire measuring patients' treatment needs and treatment benefits for skin diseases. The PBI comprises two components: 1. Patient Needs Questionnaire measuring the importance of different treatment goals from the patient perspective. 2. Patient Benefit Questionnaire measuring the achievement of the treatment goals from the patient perspective.
Skin reaction evaluation
时间窗: Week 3 of immunotherapy (end of study)
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) will be used to evaluate the skin reactions in the cancer patients
次要结局
- Quality of life - Skindex-29(Week 3 of immunotherapy (end of study))
- Quality of life -DLQI(Week 3 of immunotherapy (end of study))
- Patient subjective evaluation of skin reactions(Week 3 of immunotherapy (end of study))
- Patients' satisfaction with the therapeutic intervention(Week 3 of immunotherapy (end of study))