Sensory Approach of Food Modifications Led by Chemotherapy

Cancer Clinical Trial

Official title:

Sensory Approach of Food Modifications Led by Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368509
• Other study ID #: 2014.871
• Secondary ID: 2014-A00742-45
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: November 22, 2017
• Start date: November 2014
• Est. completion date: November 16, 2017

Study information

• Verified date: November 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Perform sensory tests

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine	Pierre Benite
France	Centre Hospitalier Lyon Sud - Service de Pneumologie	Pierre Benite
France	Institut de Cancérologie de la Loire	Saint Priest En Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Link
•   Link
•   Link