Sensory Approach of Food Modifications Led by Chemotherapy

NCT02368509 | Completed

• 2 other identifiers: 2014.8712014-A00742-45
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

sensory test; olfaction; gustation; taste; cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Bronchial cancer

EXPERIMENTAL

Patients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy.

Other: Perform sensory tests

Control group

PLACEBO COMPARATOR

Healthy individuals will perform sensory tests before and after a 6-week period without chemotherapy.

Other: Perform sensory tests

Interventions

Perform sensory tests OTHER

Bronchial cancer; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women
• Age ≥ 18 years old
• People capable of giving their consent and of understanding the study
• ≤ 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Centre de Recherche en Nutrition Humaine

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Lyon Sud - Service de Pneumologie

Pierre-Bénite, 69310, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (1)

• 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.

  PMID: 36701841 RESULT

Related Links

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MeSH Terms

Conditions

Neoplasms; Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: February 23, 2015
• Study Start: November 1, 2014
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

FR (3)