Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

Not yet recruiting

• Conditions: Digestive Cancers; Breast Cancer; Gynecologic Cancer; Lung Cancer; Nose Cancer; Throat Cancer; Ear Cancer

• Registration Number: NCT06803381
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Study Start: 2025-03-13
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS) score	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).

Trial Locations

Locations (2)

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

Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse; 🇫🇷 Lyon, France