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

Civil Hospices of Lyon

Status: Not yet enrolling

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

Treatments: Other: Salivary test; Other: Questionnaires; Other: Food tasting; Other: sensory capacity evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT06803381

2024-A02687-40 (Other Identifier)

69HCL24_0539

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

96 participants in 1 patient group

Patients with cancer and under treatment from at least two months.

Description:

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

Treatment:

Other: sensory capacity evaluation

Other: Food tasting

Other: Questionnaires

Other: Salivary test