Sensory Approach of Food Modifications Led by Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- Change in Pleasantness judgments in the European Test of Olfactory Capabilities (ETOC)
研究概览
简要总结
The aim of the present study was to evaluate the impact of chemotherapy on sensorial perception in lung cancer patients in comparison to a control group (individuals without lung cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44 patients and 44 controls will be tested for olfactory and gustatory abilities before and after treatment (for patients) and for two sessions separated by the same duration for controls. Primary measure outcome will be to examine the impact of treatment on the perception of hedonic valence of odors. Secondary measure outcome will include odor and taste perceptual changes and questionnaires on eating habits and behaviors, in order to examine the impact of treatment on odor, taste and food perception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Men or women
- •Age ≥ 18 years old
- •People capable of giving their consent and of understanding the study
- •18 ≤ BMI < 30 kg/m²
- •Control group:
- •controlled blood pressure
- •absence of pathology which can interfere with the criteria of the study (ENT, neurological, digestive,...)
- •absence of treatment which can interfere with the criteria of the study
- •absence of digestive disorders
- •women with contraception
- •Patients affected by a bronchial cancer (post-operative or metastatic) with small cells or not, that must be handled by a chemotherapy with salts of platinum (at least 3 cycles)
- •patients without previous chemotherapy
- •Absence of ENT or neurological pathologies
排除标准
- •Subjects having lost more than 10 % of their weight in the previous 2 months
- •Symptomatic intellectual and/or meningeal metastases
- •Mycosis of oral or superior digestive tract
- •Cancer of ENT or esophageal or gastric ways
- •Patients with digestive disorders (≥ rank 1)
- •Patients presenting a pathology which can interfere with the study
研究组 & 干预措施
Bronchial cancer
Patients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy.
干预措施: Perform sensory tests (Other)
Control group
Healthy individuals will perform sensory tests before and after a 6-week period without chemotherapy.
干预措施: Perform sensory tests (Other)
结局指标
主要结局
Change in Pleasantness judgments in the European Test of Olfactory Capabilities (ETOC)
时间窗: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
Fed state This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects. Unit of measure: A visual scale is used to collect a score from 1 (very unpleasant) to 9 (very pleasant).
次要结局
- Change in Intensity judgment (IJ-8odor) of odors in the 8-odor test(Before (day 1) and after the 6-week period (day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Warmness judgments (WAJ) of odors for the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Irritation judgments (IRJ) of odors for the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Olfactory detection (OD-ETOC) with the ETOC test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Olfactory identification (OI) in the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Gustatory detection (GD) in the Taste Strips test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Pleasantness judgment (PJ-Taste) of tastes in the Taste Strips test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Edibility judgment (EJ-ETOC) of odors in the ETOC test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Edibility judgment (EJ-8odor) of odors in the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Intensity judgment (IJ-ETOC) of odors in the ETOC test(Before (day 1) and after the 6-week period (day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Intensity judgment (IJ-Taste) of tastes in the Taste Strips test(Before (day 1) and after the 6-week period (day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Familiarity judgment (FJ-Taste) of tastes in the Taste Strips test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Familiarity judgment (FJ-ETOC) of odors in the ETOC test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Pungency judgments (PUJ) of odors for the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Coolness judgments (COJ) of odors for the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- practices and food habits(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Familiarity judgment (FJ-8odor) of odors in the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Gustatory identification (GI) in the Taste Strips test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Pleasantness judgment (PJ-8odor) of odors in the 8-odor test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))
- Change in Olfactory identification (OI-ETOC) in the ETOC test(Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion))