Impacts of Oral Supplement With L-Glutamine on the Radiation-induced Toxicity and Nutritional Status of Head and Neck Cancer Patients Under Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- grade of oral mucositis
研究概览
简要总结
The rapidly increasing mortality and incidence of oral cancer has become a public health major problem in Taiwan. To date, the treatment of head and neck cancer mainly include surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an influence on the patients' diet by causing dismal side effects, including nausea, vomiting, pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the patients more difficult to absorb nutrients. In the previous study, the incidence of malnutrition among the patients with cancer has been estimated at between 40 and 80%, especially occurred in the patients with head and neck cancers and upper gastrointestinal cancers.
In this study, the effect of supplement with L-Glutamine on the nutritional status and radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the patients' quality of life when they are undergoing radiotherapy. When the head and neck cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of L-Glutamine are performed to maintain the patients' nutritional status and reduce the patients' diet-related or other side effects caused by radiotherapy. It is anticipated that head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might decrease treatment-related side effects and hence improve their quality of life when they are undergoing radiotherapy.
详细描述
- Written informed consent must be obtained before any study specific procedures are undertaken.
- The process of the experiment A. head and neck cancer patients with surgery and radiotherapy are identified in clinic at the Department of Dentistry and the Department of Radiotherapy in Kaohsiung Medical University Chung-Ho Memorial Hospital.
B. Inform these patients about the value of this clinical trial in detail, and make sure that they understand all the meanings of each procedure in this clinical trial. Subsequently, the patients who are willing to participate in this study are enrolled after completing institutionally approved informed consent.
C. In order to assess the effect of supplement with L-Glutamine on the nutritional status and diet of head and neck cancer patients with surgery and radiotherapy, the enrolled patients will be divided into two groups randomly. One group is supplied with 10 g L-Glutamine and 5 g maltodextrin; the other group is supplied with 15 g maltodextrin as control group. The patients of these two groups take their supplemental nutrients three times a day, respectively, in a period of time of 7 days before radiotherapy to 14 days after radiotherapy.
D. Meanwhile, the research assistants will monitor the patients' condition carefully by recording their daily diet, nutritional status and side effects caused by radiotherapy at three specific time-points during the whole clinic trial program course.
E. The monitor items of patients' nutritional status include the daily diet of patients before and after radiotherapy by recording 24 hr recall table and food frequency table,(b) the physical examination of height, weight, ideal weight, tricept skinfold (TSF), mid-arm circumference (MAC) and mid-arm muscle circumference (MAMC), (d) prognostic nutritional index (PNI), (e) biochemistry inspection assessment and (g) complete blood count (CBC).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis of malignant head and neck tumor.
- •able to open his or her mouth wider than the width of one finger during the assessment of oral mucositis.
- •Eastern Cooperative Oncology Group（ECOG）0-2
- •complete radiotherapy (six to seven weeks with targets involving oral cavity or oropharynx)
排除标准
- •History of previous radiotherapy.
- •diabetes or nephritic or hepatic problems.
- •serious infection or sepsis.
- •distant metastases
结局指标
主要结局
grade of oral mucositis
时间窗: once a week during radiotherapy and once after radiotherapy up to 8 weeks
Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
grade of neck dermatitis
时间窗: once a week during radiotherapy and once after radiotherapy up to 8 weeks
Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
次要结局
未报告次要终点