Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis. An Observer-masked, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants With Progression of Radio Therapy Induced Skin Reaction
研究概览
简要总结
This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion.
The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period
详细描述
This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion.
The aim of this clinical study is to collect controlled evidences of the effectiveness and tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast cancer who will start the treatment with the product about one week before the start of RT.
The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessments and evaluations will be performed by a physician in a blind fashion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who give their written consent for participation in the study and willing to comply with all its procedures.
- •Age ≥18 years.
- •Women with breast cancer at any stage who have undergone quadrantectomy, for whom hypofractionated adjuvant RT of the thoracic region is indicated.
- •RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in the region to be treated, according to investigator's judgement.
- •Patients who are supposed to be cooperative with regard to compliance with study-related constraints.
排除标准
- •Pregnant or lactating women (as not eligible to RT), and fertile women not following, at the investigators' judgement, an adequate contraceptive method.
- •Subjects incapable of giving consent.
- •Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea.
- •Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus erythematosus.
- •Unhealed surgical sites, breast infections.
- •Bilateral breast cancer or multiple neoplasia needing other independent RT treatments.
- •Prior breast reconstructions, implants, and/or expanders.
- •Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia).
- •Known history of intolerance or hypersensitivity to any ingredient of the study products.
- •Previous RT in the same or different location.
- •Topical pharmacological and medical device treatments on the skin region affected by the RT, in the last 2 weeks.
- •Systemic or topical (including inhaled or intranasal) treatments containing corticosteroids of any class in the 2 days preceding the enrolment.
- •Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be administered during the course of the study.
- •Participation in another clinical trial at the time of the randomization or within 28 days before randomization.
- •Patient's difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.
研究组 & 干预措施
DermoRelizema cream
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
干预措施: DermoRelizema cream (Device)
Dexeryl
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
干预措施: Dexeryl (Device)
结局指标
主要结局
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
时间窗: two weeks after the last RT sessiont,day 35-42
Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity
次要结局
- Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)(at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56)
- Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)(up to 1 year)
- Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)(all study visits, day 21-28, day 35-42 and at the study end (day 49-56))
- Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale(all study visits, day 21-28, day 35-42 and at the study end (day 49-56))
- Number of Participants With Progression of Radio Therapy Induced Skin Reaction(all study visits, day 21-28, day 35-42 and at the study end (day 49-56))
- Patient Opinion on Cream With a Likert Scale(up to 1 year)
- Adherence to Treatment of Patients(up to 1 year)
- Occurrence of Adverse Events(up to 1 year)