Somesthesia in Cancer Patients: Variability and Influence on Eating Experience (SOMEST'ALIM2)

Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life.

Cancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients.

SOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version.

Patients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire.

In a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Gynecologic Cancer; Lung Cancer; Ear Cancer; Nose Cancer; Throat Cancer; Digestive Cancers
• Intervention / Treatment: Other: Salivary test; Other: Food tasting; Other: Questionnaires; Other: sensory capacity evaluation

• Study Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

• Study Contact: Name: Dr. Amandine BRUYAS, MD, PhD; Phone Number: +33 4.78.86.16.28; Email: amandine.bruyas@chu-lyon.fr
• Study Contact Backup: Name: Irina-Elena ANTOCHI, Project manager; Phone Number: +33 4.78.86.43.22; Email: irina-elena.antochi@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69003
    • Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot
    • Contact: Patrick ROBELIN, MD, PhD; Phone Number: +33 4.72.11.26.60; Email: patrick.robelin@chu-lyon.fr
    • Contact: Patrick ROBELIN, MD, PhD
  • Lyon, France, 69004
    • Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse
    • Contact: Amandine BRUYAS, MD, PhD; Phone Number: +33 4.78.86.16.28; Email: amandine.bruyas@chu-lyon.fr
    • Contact: Amandine BRUYAS, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with different types of cancer: digestive, breast, gynecologic, ENT, lung and aged between 18 and 70 years.

Description

Inclusion Criteria:

• Patient between 18 and 70 years old
• Patient with digestive, breast, gynecologic, ENT or lung cancer
• Patient receiving a cancer treatment from at least two months
• Patient having given his free, informed and express written consent

Exclusion Criteria:

• Patient having a radiotherapy treatment for an ENT cancer
• Patient with a known food allergy/intolerance to food samples (which may contain dairy products)
• Patient unable to swallow soft food
• Patient having presented nausea and vomiting during the last 24 hours
• Patient with severe inflammation of the mouth or throat (ulcers, mucus)
• Patient with cognitive disorders and memory loss
• Pregnant women or breastfeeding
• Adult under legal protection (guardianship)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with cancer and under treatment from at least two months.; The study will involve adult subjects with different types of cancer (digestive, gynecological, breast, ENT, lung) receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing ENT radiotherapy) in a standard of care program. Patients participating to the trial will perform a salivary test, an evaluation of the sensory capacity, food tasting and will answer to different questionnaires

Other: Salivary test; In order to determine the quantity and quality of patients saliva before food tasting a saliva test will be performed using a Saliva-Check BUFFER kit. A small quantity of saliva will be collected and discarded immediately after the test result obtained. The test will be done only once for each patient.; Other: Food tasting; Patients will be invited to taste four different food samples, 2 sweet and 2 salty samples, and to evaluate them using a visual analog scale (0 : I don't like at all to 100 : I like a lot). The intervention will be done once for each patient during one of their standard of care treatment visit.; Other: Questionnaires; Patients will be invited to answer to some questionnaires : socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, QLQ-C30 quality of life and food quality of life questionnaire. They will answer to all questionnaires only once during participation to the study.; Other: sensory capacity evaluation; For the sensory capacity the test 6-n-propylthiouracil (PROP) taste strip will be used. One tasting strip will be placed on the tongue and patients will be asked to assess the intensity of bitterness. The test will be done only once for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS) score	The score difference of a visual analogue scale (VAS) (0 : I don't like at all to 100 : I like a lot) will be used to evaluate perception of patients with cancer on two different versions of food. The scale unit will be in mm and the difference in VAS score between the two food categories will be compared (hedonic delta).	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Dr. Amandine BRUYAS, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): March 13, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; nutrition; food; somesthesia; perceptions
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Bone Neoplasms; Head and Neck Neoplasms; Respiratory Tract Neoplasms; Nose Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Otorhinolaryngologic Neoplasms; Skull Neoplasms; Nose Neoplasms; Ear Neoplasms
• Other Study ID Numbers: 69HCL24_0539; 2024-A02687-40 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No