Clinical trial NCT06803381: Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
Official title: Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Digestive Cancers
Breast Cancer
Gynecologic Cancer
Lung Cancer
Nose Cancer
Throat Cancer
Ear Cancer
Keywords: Cancer
nutrition
somesthesia
food
perceptions
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: visual analogue scale (VAS) score
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot
city: Lyon
country: France
facility: Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Dr. Amandine BRUYAS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: