Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Measurement of implicit wanting by the LFQP-France questionnaire
研究概览
简要总结
The study will be offered to patients with non-small cell lung carcinoma diagnosed at stage IV and receiving first-line treatment.
The patient will benefit from a complete assessment at inclusion (clinical exam, imagery, biological exam, dietary consultation, test LFQP.
At the end of this 1st evaluation, patients in whom the diagnosis of undernutrition is made will benefit from dietary management with personalized advice that will take into account the symptoms of cancer, the possible side effects of treatments as well as the social environment.
Every two cures, i.e. every 4 to 6 weeks, these examens will be performed until the occurrence of an event (progression of the disease according to the RECIST criteria, death or change of therapeutic line). At the end of these assessments, patients will benefit from dietary management with a readjustment of personalized advice that will take into account the difficulties highlighted during the assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage IV non-small cell lung carcinoma with indication for first-line systemic treatment (chemotherapy, immunotherapy or specific treatment, in particular tyrosine kinase inhibitors) according to current French recommendations.
- •Age over 18 and under 70
- •Patient speaking and reading French fluently
- •Affiliation to a social security scheme
- •Patient able and willing to follow all study procedures in accordance with the protocol
- •Patient having understood, signed and dated the consent form
排除标准
- •Patient requiring hospitalization for more than 48 hours for the administration of the first course of treatment
- •Patient benefiting from antibiotic therapy for the treatment of an acute infection
- •Psychiatric, cognitive or neurological disorders making it impossible to assess food preferences and/or any impossibility to undergo medical monitoring for the trial for geographical, social or psychological reasons.
- •Daily alcohol consumption
- •Chest radiotherapy treatment
- •Pregnant woman, likely to be, or breastfeeding
- •Persons deprived of liberty or under guardianship
结局指标
主要结局
Measurement of implicit wanting by the LFQP-France questionnaire
时间窗: During patient follow-up (12 months max)
The food category with the highest implicit wanting score will be retained as characterizing the patient's food preferences. The 4 categories concerned are as follows: * salty high in fat * salty-low fat * sweet-high fat * sweet-low fat
次要结局
- The impact of food preferences (liking, explicit lwanting and implicit wanting) assessed by the LFQP-France questionnaire on the severity of undernutrition(through study completion, an average of 1 year)
- The occurrence of undernutrition within 6 months after inclusion, in patients not undernourished at inclusion(During 6 months)
- the impact of food preferences (liking, explicit wanting and implicit wanting) assessed by the LFQP-France questionnaire on quality of life(through study completion, an average of 1 year)
- The impact of food preferences (liking and explicit wanting) assessed by the LFQP-France questionnaire on the prevalence and incidence of undernutrition in the 6 months after inclusion.(During 6 months)
- The impact of the type of 1st line treatment on food preferences (chemotherapy based on platinum salt versus immunotherapy versus targeted therapy)(through study completion, an average of 1 year)