Cancer
Conditions
Keywords
sensory test, olfaction, gustation, taste, cancer
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.
Interventions
OTHERPerform sensory tests
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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-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 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 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 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 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 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 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 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-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. |
| 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 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 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). |
| 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 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). |
Countries
France
Outcome results
None listed