Clinical trial NCT02368509: Sensory Approach of Food Modifications Led by Chemotherapy
Official title: Sensory Approach of Food Modifications Led by Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: sensory test
olfaction
gustation
taste
cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pleasantness judgments in the European Test of Olfactory Capabilities (ETOC)
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
Secondary outcomes:
measure: Change in Intensity judgment (IJ-ETOC) of odors in the ETOC test
timeFrame: Before (day 1) and after the 6-week period (day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Intensity judgment (IJ-8odor) of odors in the 8-odor test
timeFrame: Before (day 1) and after the 6-week period (day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Intensity judgment (IJ-Taste) of tastes in the Taste Strips test
timeFrame: Before (day 1) and after the 6-week period (day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Familiarity judgment (FJ-ETOC) of odors in the ETOC test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Familiarity judgment (FJ-8odor) of odors in the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Familiarity judgment (FJ-Taste) of tastes in the Taste Strips test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Edibility judgment (EJ-ETOC) of odors in the ETOC test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Edibility judgment (EJ-8odor) of odors in the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Pungency judgments (PUJ) of odors for the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Warmness judgments (WAJ) of odors for the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Coolness judgments (COJ) of odors for the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Irritation judgments (IRJ) of odors for the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Olfactory detection (OD-ETOC) with the ETOC test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Olfactory identification (OI-ETOC) in the ETOC test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Olfactory identification (OI) in the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Gustatory detection (GD) in the Taste Strips test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Gustatory identification (GI) in the Taste Strips test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Pleasantness judgment (PJ-8odor) of odors in the 8-odor test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: Change in Pleasantness judgment (PJ-Taste) of tastes in the Taste Strips test
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
measure: practices and food habits
timeFrame: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Centre de Recherche en Nutrition Humaine
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud - Service de Pneumologie
city: Saint Priest En Jarez
country: France
facility: Institut de Cancérologie de la Loire
Study officials:
References: