The Efficacy of the Medical Device Jalosome® Soothing Gel in the Healing of Grade of 2 or 3 Radiodermatitis, Pain Intensity Reduction, as Well as Improvement of QoL in Oncology Patients: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Grade 2 or 3 radiodermatitis healing
研究概览
简要总结
Testing the efficacy of the Jalosome® Soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients.
The investigators would like to know also the efficacy of the device on quality of life and pain.
详细描述
The overall objective of the study is to evaluate the efficacy of the class IIA medical device Jalosome® soothing gel in the healing of grade 2 or 3 radiodermatitis, in oncology patients undergoing radiotherapy treatment, during a 8-week observation period.
The secondary endpoints are radiodermatitis pain control and quality of life.
The investigators would like to involve 30 oncology patients. All oncology diagnosis will be included in this pilot study. The study will adopt a quasi-experimental design with one arm. The results will be used to determine the sample size for a clinical trial in which the class IIA medical device Jalosome® soothing gel will be compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients aged ≥18 years
- •Patients with cancer* undergoing radiotherapy treatment
- •Patients with grade 2 or 3 radiotherapy lesions who are naive to radiodermatitis treatment or unresponsive to previous treatment
- •Patients who have given written informed consent
- •Patients expected to be followed at the centre for at least 8 weeks
- •Patients with Karnofsky Performance Status(KPS) scale ≥ 40
排除标准
- •Patients with grade 1 and grade IV radiodermatitis
- •Patients with known intolerance to the components in Jalosome® soothing gel
- •Patients who have already received radiotherapy in the past on the irradiated area
- •Patients with cognitive impairment that does not allow adequate compliance with the protocol
- •Patients with brain metastases
- •Pregnant or lactating patients
- •Patients with KPS < 40
研究组 & 干预措施
Jalosome® Soothing gel
The medical device will be applied by the patient himself, after appropriate training carried out by the nurse, twice a day, in the quantity necessary to cover the lesion (0.2g of gel /16 cm2 of skin (one spray), repeated as many times as necessary to cover the entire lesion). The treatment will last 8 weeks.
The medical device will be delivered in the quantity strictly necessary to carry out the therapies between visits, in order to monitor its use. Patients will be seen weekly by the nurse, in order to ensure the best continuity of care and promote adherence to the study. Patients will be asked to keep a weekly diary, in which they will report their level of pain, analgesic therapy and medication. Nurses will be available for telephone counselling, if necessary.
干预措施: Jalosome soothing gel (Device)
结局指标
主要结局
Grade 2 or 3 radiodermatitis healing
时间窗: 8 weeks
The primary endpoint is the number of grade 2 or 3 radiodermatitis healed by the application of Jalosome® soothing gel during the observation period, out of the total number of patients treated. This endpoint will be assessed by photographic documentation of lesion improvement and healing and with the aid of the RGOT scale (which should regress from grade 2 or 3 to grade 0 or 1). The time to regression of the lesion will also be monitored on this same endpoint in order to establish the rate of efficacy of the product against grade 2 and 3 lesions.
次要结局
- Skindex questionnaire - 16 for quality of life(at the beginning, after 4 weeks and after 8 weeks)
- Pain quality and intensity(8 weeks)