Sensory Approach of Food Modifications Led by Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Sensory Approach of Food Modifications Led by Chemotherapy

Conditions
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Cancer

Intervention / Treatment
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* Other: Perform sensory tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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 Exclusion Criteria: - Subjects having lost more than 10 % of their weight in the previous 2 months Patients: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchial cancer<br>Patients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy. | Other: Perform sensory tests<br> <br> |
| Placebo Comparator: Control group<br>Healthy individuals will perform sensory tests before and after a 6-week period without chemotherapy. | Other: Perform sensory tests<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pleasantness judgments in the European Test of Olfactory Capabilities (ETOC) | 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). | Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intensity judgment (IJ-ETOC) of odors in the ETOC test | 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 (no odor) to 9 (very intense odor). | 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-8odor) of odors in the 8-odor test | 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 (no odor) to 9 (very intense odor). | 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 | 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 (no taste) to 9 (very intense taste). | 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-ETOC) of odors in the ETOC test | 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 (unknown odor) to 9 (very known odor). | 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 | 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 (unknown odor) to 9 (very known odor). | Before (Day 1) and after treatment (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 | 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 (unknown taste) to 9 (very known taste). | 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 | 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 (not edible) to 9 (very edible). | 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 | 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 (not edible) to 9 (very edible). | 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 | 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 (not at all pungent) to 9 (very pungent). | Before (Day 1) and after treatment (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 | 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 (not at all warm) to 9 (very warm). | 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 | 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 (not at all cool) to 9 (very cool). | 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 | 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 (not at all irritant) to 9 (very irritant). | 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 | 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 score from 0 (no odor detected) to 16 (all odors detected) is collected. | 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 | 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 score from 0 (no odor identified) to 16 (all odors identified) is collected. | 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 | 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 score from 0 (no odor identified) to 8 (all odors identified) is collected. | 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 | 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 score from 0 (no taste detected) to 4 (all tastes detected) is collected. | 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 | 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 score from 0 (no taste identified) to 4 (all tastes identified) is collected. | 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 | 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 odor) to 9 (very pleasant odor). | 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 | 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 taste) to 9 (very pleasant taste). | Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion) | 
| practices and food habits | Practices and food habits will be evaluated before and after the 6-week period. Food odors which appeared less or more agreeable the weeks before the survey will also be evaluated before and after the 6-week period. Unit of measure: these measures are qualitative; the results will be expressed in percentage of given responses. | Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensory test, olfaction, gustation, taste, cancer