Can Cytokines Predict the Severity of Acute Mucositis and the Need for PEG During Chemo-Radiation Treatment to Head and Neck Cancer?
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
Mucositis and xerostomia are the most common complications of head and neck (H&N) irradiation, and the combination of chemotherapy and radiation therapy is associated with a significantly higher rate of complications.
Mucositis usually develops during the second or third week of a course of standard radiotherapy, and the pain it causes peaks between the third and last week of treatment. The pain then persists for at least one month following the completion of therapy, and may be so overwhelming that it prevents patients from swallowing food and fluids. The patient is therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect, the use of gastrostomy tubes (PEG) has been shown to be beneficial.
Completion of the full course of irradiation, without interruption, is important for achieving best possible results in cancer of the H&N. It is therefore essential to identify and refer patients at risk to receive effective and timely nutritional intervention.
Since mucositis represents a clinical continuum which differs between patients, it is difficult to assess before-hand which patients will be at risk.
There is no simple laboratory tool available, which could predict which patients are susceptible to develop severe mucositis and dysphagia, and eventually will require a feeding gastrostomy.
The first phase of mucositis, inflammation, results in the production of pro-inflammatory cytokines such as interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α).
In general, the inflammatory cytokines IL-1, interleukin-6 (IL-6) and TNF-α are elevated in inflammatory conditions and are found in increased levels in blood and tissue fluid during inflammation, while anti-inflammatory cytokines are produced in a decreased manner.
The main purpose of this study is to find the best indicators and prognosticators of mucositis occurring in the healthy oral tissues of H&N cancer patients receiving treatment, and to understand the cytokines balance mechanism of action.
Assuming there is a correlation between high cytokines levels during inflammation and the severity of radiation induced mucositis, finding these prognostic factors may help us predict during the first part of the treatment the need for PEG, placing it prior to the complications associated with severe mucositis on one hand, and avoiding unnecessary procedures on the other hand.
详细描述
Mucositis has a significant detrimental effect on patient's quality of life in terms of pain, ability to eat, to swallow and talk. It may be so severe that an interruption of therapy is required, consequently influencing tumor response and overall patient outcome.
The degree of mucositis varies between different patients: some patients may develop a limited condition, confined to patches of mildly sore erythematous mucosa, while others may experience diffuse areas of painful ulceration.
In the more severe cases, pain may be so overwhelming that it prevents patients from swallowing food and fluids. The patient is therefore at a risk to develop malnutrition, and must be treated vigorously. In this respect, the use of gastrostomy tubes (PEG) has been shown to be beneficial.
Another aspect of radiation induced mucositis is its health-care costs. Patients with more severe mucositis have statistically greater outpatient support costs; these include maintenance of appropriate nutritional and hydration support, such as placement of gastrostomy tubes. In the U.S, the mucositis overall medical costs are in the order of approximately $3000±$1000, per treatment.
Completion of the full course of irradiation, without interruption, is important for achieving best possible results in cancer of the H&N. It is therefore essential to identify and refer patients at risk to receive effective and timely nutritional intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with H&N epithelial cancer (nasopharynx, oropharynx, oral cavity - tongue, buccal mucosae and palate, larynx and hypopharynx)
- •Treated with definitive chemo-radiation treatment and follow up
- •Male and female patients will be included, with an age ranging between 18- 85 years
排除标准
- •Soldiers, prisoners and pregnant women will be excluded.
