Sensory Approach of Food Modifications Led by Chemotherapy

Civil Hospices of Lyon

Status: Completed

Conditions: Cancer

Treatments: Other: Perform sensory tests

Study type: Interventional

Funder types: Other

Identifiers

NCT02368509

2014-A00742-45 (Other Identifier)

2014.871

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups, including a placebo group

Bronchial cancer

Experimental group

Description:

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

Treatment:

Other: Perform sensory tests

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Perform sensory tests