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NCT Number: NCT06803381

Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

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.

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Key information

Conditions

Digestive Cancers Bone Diseases Bone Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Ear Cancer Ear Diseases Ear Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecologic Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Nose Cancer Nose Diseases Nose Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Skull Neoplasms Thoracic Neoplasms Throat Cancer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot, Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Salivary test

Other

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.

Food tasting

Other

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.

questionnaires

Other

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.

sensory capacity evaluation

Other

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.

Primary outcomes

visual analogue scale (VAS) score

Time frame: Day 1

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Amandine BRUYAS, MD, PhD

CONTACT

[email protected]

+33 4.78.86.16.28

Irina-Elena ANTOCHI, Project manager

CONTACT

[email protected]

+33 4.78.86.43.22

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SOMEST'ALIM2

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 31, 2025
Registry last updated: Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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