Sensory Approach of Food Modifications Led by Chemotherapy (ARC-1)

August 8, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Benite, France, 69310
        • Centre de Recherche en Nutrition Humaine
      • Pierre Benite, France, 69310
        • Centre Hospitalier Lyon Sud - Service de Pneumologie
      • Saint Priest En Jarez, France, 42270
        • Institut de Cancerologie de La Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

February 16, 2015

First Posted (Estimated)

February 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014.871
  • 2014-A00742-45 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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