NCT03255980已完成不适用
Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
研究概览
简要总结
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head & neck cancer patients.
详细描述
The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head & neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male and female which are 18 years of age or older
- •Performance status < 2
- •Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
- •Postoperative or curative radiation treatment
- •Concurrent chemotherapy is accepted, in head & neck cancer patients
- •Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.
排除标准
- •Pregnant or lactating women
- •Planned to receive concurrent cetuximab
- •Previous radiation therapy on the head and neck area or breast and thorax areas
- •Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)
- •Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure
- •Use of a tissue-equivalent bolus
- •Use of over-the-counter topical medications containing steroids
- •Presence of rashes or unhealed wounds in the radiation field
- •Recent sun exposure
- •Mental conditions that could adversely affect patients' adherence to the study.
结局指标
主要结局
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
时间窗: 5 weeks over 7 weeks
The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis \< G2) at week 5
次要结局
- The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.(Follow-up: 2 weeks after the completion of radiation treatment)
- Median Time to G2 Radiodermatitis Development(5 weeks over 7 weeks)
- The Mean and Worst Score of Skindex-16 Questionnaire(5 weeks over 7 weeks)
- The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale(6 weeks over 7 weeks)
- The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites(5 weeks over 7 weeks)
- The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation(6 weeks over 7 weeks)
- The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation(weekly during teratment (7 weeks))
- The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product(5 weeks over 7 weeks)
研究者
研究点 (2)
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