Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Worst skin toxicity
研究概览
简要总结
There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance.
XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and pruritus, induced by radiotherapy or other causes.
详细描述
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients in the Institution.
Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques (IMRT or volumetric modulated radiotherapy, VMAT) with conventional fractionation at total dose of 50-66 GY in postoperative setting and 66-70 Gy in radical setting. Radiotherapy will be planned with simultaneous boost (SIB) approaches, using conventional fractionation (1.8-2.12 Gy/die). According to histology, stage and pathology reports, patients could receive concomitant platinum based chemotherapy.
The patients will be evaluated at baseline, at weekly intervals during RT and six months after treatment completion by 2 different treating physicians for each visit. The evaluation will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology Group (RTOG), and patient-reported outcome measured using the Skindex-16 questionnaire.
In addition objective in vivo measurements of skin erythema and pigmentation based on reflectance spectrometry (RS) will be performed.
Measurements will be performed before RT, every 5 RT fractions (once a week) up to the end of RT and 6 months after RT completion (same timing as clinical evaluation). Instrumental RS measurement will be performed at five different fixed regions within the area treated with RT, in any cases only on flat skin regions of the neck in an area corresponding to the second node level and in absence of hair or nevus.
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
- •> 18 years
- •Performance status < 2
- •Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands
- •Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level of neck nodes irradiated
- •Postoperative or curative radiation treatment
- •Concurrent platinum based chemotherapy is accepted, but not mandatory
- •Conventional fractionation (1.8-2.12 GY per fraction, one daily fraction, 5 fractions a week )
排除标准
- •Pregnant or lactating women
- •Planned to receive concurrent cetuximab
- •Previous radiation therapy on the head and neck area
- •Cutaneous and connettive 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
Worst skin toxicity
时间窗: 14 months
Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians
次要结局
- Compliance(14 months)
- Median time to G2 radiation dermatitis development(14 months)
- MeanPatient Reported Outcome (PRO)(14 months)
- Grade of late toxicity(14 months)