Sensory Approach of Food Modifications Led by Chemotherapy

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Perform sensory tests

• Registration Number: NCT02368509
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2015-02-16
• Study First Posted: 2015-02-23
• Status Verified: 2017-11
• Primary Completion: 2017-11-16
• Study Completion: 2017-11-16
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchial cancer	Perform sensory tests	Patients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy.
Control group	Perform sensory tests	Healthy individuals will perform sensory tests before and after a 6-week period without chemotherapy.

Primary Outcome Measures

Name	Time	Method
Change in Pleasantness judgments in the European Test of Olfactory Capabilities (ETOC)	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).

Secondary Outcome Measures

Name	Time	Method
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)	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).
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)	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).
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)	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).
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)	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.
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)	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.
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)	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.
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
practices and food habits	Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)	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.
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)	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).
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)	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.
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)	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).
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)	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.

Trial Locations

Locations (3)

Institut de Cancérologie de la Loire; 🇫🇷 Saint Priest En Jarez, France

Centre de Recherche en Nutrition Humaine; 🇫🇷 Pierre Benite, France

Centre Hospitalier Lyon Sud - Service de Pneumologie; 🇫🇷 Pierre Benite, France