Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Grade 3 or Higher Adverse Events
研究概览
简要总结
This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.
详细描述
This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy.
Patients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy.
Information collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 or female patients ≥ 18 years of age
- •Karnofsky performance status > 70
- •Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- •No prior radiotherapy to the head and neck region.
- •No previous systemic chemotherapy or targeted therapy
- •Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
- •Patients using standard therapies for cetuximab-induced acne-form rash will be included.
排除标准
- •Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
- •Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
- •Concurrent serious infection
- •Continued use of Niacin
结局指标
主要结局
Grade 3 or Higher Adverse Events
时间窗: Up to 12 months
Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
次要结局
- University of Washington Quality of Life Questionnaire (UW-QOL)(after 16.5 months, up to 48.9 months)
- Brief Pain Inventory (BPI)(after 16.5 months, up to 48.9 months)
- Dermatology Life Quality Index (DLQI)(after 16.5 months, up to 48.9 months)
研究者
Heath Skinner
Radiation Oncologist
University of Pittsburgh