Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate of occurence of radiation mucositis
研究概览
简要总结
Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer
Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context.
详细描述
Introduction: Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer
Rationale: Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context.
Purpose/Objectives: Primary Objective Primary Objective
• To determine the cumulative incidence of acute mucositis as defined by CTCAE version 2.0 for radiation induced mucositis (Appendix 1) during radiotherapy and for 1month following radiotherapy
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age ≥ 18 years of age
- •Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)
- •Histological diagnosis of head and neck cancer of the oral cavity with no evidence of macroscopic residual disease post-surgery (R0 or R1 resection) and no gross residual lymphadenopathy in the planned PBM treatment area
- •Planned treatment with radiotherapy or chemoradiotherapy to a dose of ≥ 50 Gy
- •ECOG Performance Status of 0 or 1
- •Intact oral mucosa (no visible ulceration, dehiscence or active infection
排除标准
- •Gross macroscopic residual disease post surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
- •Prior radiotherapy to the Head and Neck including the oral or oropharyngeal mucosa.
- •Prior cytotoxic chemotherapy in the last 3 months
- •Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
- •Concurrent administration of Cetuximab
研究组 & 干预措施
Photobiomodulation
Parameters: combined 633nm and 870 nm @1000mW
- 1 Treatment pre radiotherapy
- 3 treatments weekly during radiotherapy
干预措施: Photobiomodulation (Device)
结局指标
主要结局
Rate of occurence of radiation mucositis
时间窗: 24 months post radiotherapy
CTCAE version 2.0
次要结局
- Brief Pain Inventory(24 months post radiotherapy)
- EQ-5D(24 months post radiotherapy)
- Radiation dermatitis(24 months post radiotherapy)
- Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)(24 months post-radiotherapy)