NCT06803381

Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 96 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Digestive Cancers
• Breast Cancer
• Gynecologic Cancer
• Lung Cancer
• Nose Cancer
• Throat Cancer
• Ear Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-13
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2025-01-31
• Last updated: 2025-02-06

Locations

2 sites across 1 country: France