Pilot Double-blind Randomized Controlled Clinical Trial for the Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dermatological Quality of Life
研究概览
简要总结
The treatment of cancer as a multidimensional disease has improved in recent years with the development of new chemotherapies, targeted biological therapies or radiation therapy protocols and have led to an overall improvement in the survival of oncology patients. These treatments often cause adverse effects on the skin, which can be accompanied by physical and mental suffering and have a significant impact on patients' quality of life. Improving the quality of life of patients is today a therapeutic challenge. The objective of this clinical study is to assess the tolerability of an innovative skin cosmetic product that will be developed specifically for use during curative anticancer treatments, as well as to study the impact on quality of life of skin side effects caused by the treatments.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age,
- •understand and be able to provide signed consent for the purpose of the research,
- •be diagnosed with breast or head and neck cancer,
- •undergo subfractionated radiotherapy of the breast in 15 sessions of a total dose of 40-42Gy, with or without the administration of a booster dose (boost),
- •to know the Greek or English language well
- •any wound should have healed after radiotherapy. The criteria will be evaluated by the medical staff of the hospital.
排除标准
- •those who do not meet the aforementioned inclusion criteria as well as:
- •those who suffer from inflammatory cancer,
- •those who have untreated wounds and/or other serious dermatological problems
- •those with severe/extensive burns
- •those who suffer from serious mental disorders (dementia, drug addiction, etc.) that require intensive treatment or monitoring,
- •those who have a sensitivity/allergy to any of the product's ingredients. The criteria will be evaluated by the medical staff of the hospital.
研究组 & 干预措施
Intervention group
50 patients will be randomized to the MEDISKIN group and 50 to the panthenol group. Everyone will start using their cream from the start of the treatment and will continue for 2 weeks after the end of the radiation therapy (twice a day). If there are cases of patients using panthenol and it is deemed necessary based on symptoms to use MEDISKIN then they will automatically change group. Before starting to use the skin cosmetic products, patients will be asked to test the product for any allergic reactions. The "mini-patch test" which is standard of practice is carried out by using the substance on the inner elbow or wrist for 24 hours and observing for any reactions.
干预措施: MEDISKIN cream (Other)
Control group
The group will be using panthenol istead of the MEDISKIN product
干预措施: Panthenol cream (Other)
结局指标
主要结局
Dermatological Quality of Life
时间窗: Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later
Questionnaire SKINDEX-17 \| The Skindex-17 is a dermatological HRQoL instrument that was derived from the Skindex-29 using Rasch psychometric analysis. It consists of 17 items instead of 29, and answers are given on a four-point scale instead of a five-point scale. The tool offers 2 measures: psychosocial health and symptomatology with higher scores reporting increased quality of life and symptomatology respectively. Change in dermatological quality of life immediately after treatment will be used as the primary outcome.
次要结局
- Real time quality of life(During therapy (15 days))
- Real time anxiety(During therapy (15 days))
- Real time depression(During therapy (15 days))
- Socio-demographic questionnaire(Baseline (1 month before radiotherapy))
- Dermatological Quality of Life (b)(Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), During therapy (15 days), 1 week post therapy)
- Real time fatigue(During therapy (15 days))
- Health Related Quality of Life(Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later)
- Real time pain(During therapy (15 days))
- Acceptability questionnaire(First day of therapy with Mediskin products (and after radiotherapy), 1 week post therapy, 1 month post baseline)
研究者
Angelos Kassianos
Lecturer
Cyprus University of Technology