StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- grade 2 acute radiation dermatitis
研究概览
简要总结
This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority of whom will be outpatients unless they require inpatient supportive care during treatment.
There will be a 12 to 14-week longitudinal follow-up with 9 assessments conducted during this follow-up.
The estimated duration of recruitment will be 6-8 years.
Intervention group If a patient is allocated to the intervention group following randomization, the patient will be treated with StrataXRT.
Control group If a patient is allocated to the control group following randomization, the patient will be treated with standard clinical practice which consists of aqueous cream.
详细描述
Clinical significance and current evidence:
Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment. Current literature does not conclusively support the use of one agent over another for prevention of radiation dermatitis. The choice of agents used in clinical practice is highly variable, with aqueous agents being one of the commonest.
Specific Aims:
The aim of this study is to evaluate if the investigational product (StrataXRT), a silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma.
Trial Design:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are 21 years of age or older
- •histological diagnosis of head and neck carcinoma available
- •patients who are to be treated with concurrent chemoradiation
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- •no known allergy to StrataXRT or silicone
- •able to give written informed consent, or have written consent given on their behalf
排除标准
- •patients who cannot apply the skin product or have it administered to them
- •patients with comorbidities and/or on medications that may alter the response of the skin e.g. connective tissue disorder
- •patients with existing rashes or wounds in the radiation field at baseline
- •patients receiving concurrent cetuximab during radiotherapy
- •previous radiotherapy to the head and neck region
- •female patients who are pregnant or breast feeding
- •unable to give written informed consent , or are unable to have written consent given on their behalf
研究组 & 干预措施
standard clinical practice (control)
aqueous cream normally prescribed by radiation oncologists
StrataXRT (intervention)
silicon-based gel for radiation dermatitis
干预措施: StrataXRT (Device)
结局指标
主要结局
grade 2 acute radiation dermatitis
时间窗: 10 weeks
when patient develops grade 2 acute radiation dermatitis as scored by Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 scale with grade 1 the mildest, Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; patchy moist desquamation; moderate edema Grade 3: moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site Grade 5: death
次要结局
- completion of scheduled post-treatment assessment at 6 weeks post-radiotherapy(12 weeks)