CancerARC-1NCT02368509

Sensory Approach of Food Modifications Led by Chemotherapy

A study testing Perform sensory tests in people with Cancer, run by Hospices Civils de Lyon at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cancer
What is being tested?: Perform sensory tests
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 3 sitesFrance
Study dates: Nov 2014to 16 Nov 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 14Show fewer

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre de Recherche en Nutrition Humaine
Pierre-Bénite, 69310
Centre Hospitalier Lyon Sud - Service de Pneumologie
Pierre-Bénite, 69310
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270

Other trials in France

About this study

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.

Conditions: Cancer
Being tested: Perform sensory tests
Keywords: sensory test, olfaction, gustation, taste, cancer
Medical subject headings: Neoplasms, Anosmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perform sensory testsOther

Study groups in NCT02368509
Study group	Role	What they receive
Bronchial cancer	Experimental	Patients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy. Receives: Other: Perform sensory tests
Control group	Placebo comparator	Healthy individuals will perform sensory tests before and after a 6-week period without chemotherapy. Receives: Other: Perform sensory tests

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)

Secondary outcomes (20)

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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)
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.
Measured: Before (Day 1) and after treatment (Day 42) - (On average 3 weeks and 9 weeks after patient's inclusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201416 Nov 2017

First posted23 Feb 2015 (estimated)
Study startNov 2014
Primary completion16 Nov 2017
Study completion16 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02368509
Sponsor's protocol ID: 2014.871
Other IDs: 2014-A00742-45
Acronym: ARC-1
Status last verified: Aug 2025
First submitted: 5 Dec 2014
Last updated: 11 Aug 2025
Results posted: No
Data monitoring committee: No

Publications

Drareni K, Dougkas A, Giboreau A, Laville M, Souquet PJ, Nazare JA, Fournel P, Bensafi M. Loss of smell in lung cancer patients undergoing chemotherapy: Prevalence and relationship with food habit changes. Lung Cancer. 2023 Mar;177:29-36. doi: 10.1016/j.lungcan.2023.01.007. Epub 2023 Jan 12.
PubMed 36701841

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sensory Approach of Food Modifications Led by Chemotherapy
ClinicalTrials.gov ID: NCT02368509
Acronym / sponsor ID: ARC-1 / 2014.871
Conditions: Cancer
Keywords: sensory test, olfaction, gustation, taste, cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: Nov 2014 (actual)
Primary completion: 16 Nov 2017 (actual)
Study completion: 16 Nov 2017 (actual)
First posted: 23 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bronchial cancer	Experimental	Other: Perform sensory testsPatients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy.
Control group	Placebo comparator	Other: Perform sensory testsHealthy individuals will perform sensory tests before and after a 6-week period without chemotherapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Men or women
Age ≥ 18 years old
People capable of giving their consent and of understanding the study
18 ≤ BMI < 30 kg/m²
controlled blood pressure

Key exclusion criteria (7 listed)

Subjects having lost more than 10 % of their weight in the previous 2 months
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Perform sensory tests	Other	Bronchial cancer, Control group

Primary outcome

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).

20 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
Results publication: PubMed 36701841Drareni K, Dougkas A, Giboreau A, Laville M, Souquet PJ, Nazare JA, Fournel P, Bensafi M. Loss of smell in lung cancer patients undergoing chemotherapy: Prevalence and relationship with food habit changes. Lung Cancer. 2023 Mar;177:29-36. doi: 10.1016/j.lungcan.2023.01.007. Epub 2023 Jan 12.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Perform sensory tests in people with Cancer, run by Hospices Civils de Lyon at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02368509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.