Preliminary Survey of Dietary Practices and Nutritional Status of Patients Treated With Radiochemotherapy for Non-small Cell Lung Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Inventory of the dietary practices
研究概览
简要总结
In recent years, fasting or the use of special diets (ketogenic, high protein, etc.), whether or not associated with food supplements, have increased substantially, particularly in oncology with the idea of improving for some of them, the tolerance of the proposed treatments, in particular emetogenic chemotherapy, or even to improve the prognosis. Although there are preclinical data on cell cultures and in rats, the clinical data supporting these practices are very fragmented, with few trials carried out and only including small cohorts, mainly in the context of breast cancers. It is therefore very difficult to respond objectively to patients asking the question of the merits of these changes in dietary practices in the management of their cancer.
The investigators want to carry out an inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. This semi-quantitative self-administered survey (answers in never / sometimes / regularly / systematically) was developed by the nutrition and radiotherapy team of the Georges-Pompidou European Hospital because there was no validated medical questionnaire on fasting or the use of special diets in oncology
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically documented inoperable stage III non-small cell lung carcinoma (no metastasis)
- •Treatment with curative intent including thoracic radiotherapy and at least one cycle of concomitant chemotherapy
- •Patient informed and having signed the consent
排除标准
- •Sequential radiochemotherapy
- •Metastatic forms from the outset
- •Ear, nose, and throat (ENT) or digestive pathologies interfering with normal oral nutrition
- •Other concurrent or pre-existing cancer for less than 5 years at the diagnosis of bronchial cancer
- •Patient under guardianship or curatorship
- •Patient with cognitive impairment
- •Patient not affiliated with a social security
- •Patient under state medical help from french government
- •Radiotherapy performed outside the AP-HP for cohort A and outside the HEGP for cohort B
结局指标
主要结局
Inventory of the dietary practices
时间窗: 1 to 15 days
Inventory of the dietary practices of participating patients and their potential interest in fasting or special diets by means of a self-administered survey completed by the patient at diagnosis before treatment. Determination of the proportions of patients who have already followed or respond favorably to the idea of fasting and/or a particular diet. The survey is semi-quantitative.
次要结局
- Evaluate the nutritional status of patients before treatement with radiochemotherapy for non-small cell lung cancer located in the thorax.(3 month)
- Evaluate the evolution of Low Density Lipoprotein (LDL) in the population.(3 month)
- Evaluate the evolution of Glycated hemoglobin (HbA1C) in the population(3 month)
- Evaluate the evolution of the index homeostasis model assessment (HOMA) in the population(3 month)
- Evaluate the nutritional status of patients in the month following the radiochemotherapy for non-small cell lung cancer located in the thorax.(3 month)
- Evaluate the evolution of total cholesterol in the population.(3 month)
- Evaluate the evolution of High Density Lipoprotein (HDL) in the population.(3 month)
- Evaluate the evolution of triglycerides in the population.(3 month)
- Evaluate the evolution of fasting glucose in the population.(3 month)
- Evaluate the evolution of nutritional status in the population of the study(3 month)
- Evaluate the evolution of uricemia in the population.(3 month)
- Evaluate the evolution of Vitamin D in the population(3 month)