Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- "Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients.
研究概览
简要总结
This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for head & neck patients treated with PBS. The investigators will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.
详细描述
This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for head & neck patients treated with PBS. The investigators will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to increase skin dose and thus risk and magnitude of radiation dermatitis. During the study, digital photos of patients' skin will be taken to assess the amount of dermatitis (redness, blistering, or peeling). Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts. The degree of skin reactions will be compared against historical occurrence rates, and the location of any skin reactions that occur will be compared against the predicted location from the computer model. This study carries the same risks as regular proton therapy. Proton therapy, like other cancer treatments, may cause side effects. Some common side effects include skin reactions (such as redness, dryness, itching, blistering, or peeling) in the treatment area. It is important to note that the "Spot Delete" technique aims to specifically address the skin reactions, so there might be a potential reduction in this particular risk.
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
- •The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
- •Patients must be ≥ 18 years old.
- •Patient must have biopsy-proven squamous cell carcinoma, originating in the oral cavity, larynx, oropharynx, nasopharynx, or hypopharynx
- •Carcinoma of the neck of unknown primary site origin may be included if p16 positive
- •Clinical stage T1-2, N0-1, N2a-N3 or T3-4, any N (AJCC, 7th ed.), including no distant metastases
- •Patient can have prior surgical resection of a primary cancer in the head and neck at any previous time
- •Previous or concurrent chemotherapy is allowed
- •No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment
排除标准
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Head and neck radiotherapy that does NOT include at least one cervical lymph node level (I, II, III, IV, or V) in the target volume.
- •Women who are pregnant.
结局指标
主要结局
"Spot Delete: Technique in Proton Therapy Reduces Radiation Dermatitis in Head and Neck Cancer Patients.
时间窗: Weekly Assessments over 10 weeks, 1 month and 6 months post treatment
Aim to test the hypothesis that the "Spot Delete" technique in proton therapy reduces radiation dermatitis in head \& neck cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. To evaluate this, the investigators will compare the extent of skin reactions in patients who receive proton therapy with the "Spot Delete" technique to historical data from patients who did not receive this treatment.
次要结局
- To investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions.(comparisons to be conducted over a 5 year period)