Sensory Approach of Food Modifications Led by Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-11-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bronchial cancer

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

Group Type EXPERIMENTAL

Perform sensory tests

Intervention Type OTHER

Control group

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

Group Type PLACEBO_COMPARATOR

Perform sensory tests

Intervention Type OTHER

Interventions

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Perform sensory tests

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes