Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

NCT06803381 | Not Yet Recruiting

• 2 other identifiers: 69HCL24_05392024-A02687-40
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Cancer; nutrition; somesthesia; food; perceptions

Outcome Measures

Primary Outcomes (1)

• visual analogue scale (VAS) score

  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).

  Day 1

Study Arms (1)

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

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

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

Interventions

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.

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

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot

Lyon, 69003, France

Location

Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Before food testing patients will perform a saliva test in order to determine their saliva quality and quantity. A Saliva-Check BUFFER kit will be used and visual hydration, saliva consistency, pH, volume and buffering capacity will be examined. Results will be available immediately, so it won't be necessary to proceed to a biological storage or laboratory analyses. Thus, samples will be discarded immediately after the test.

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Breast Neoplasms; Lung Neoplasms; Nose Neoplasms; Ear Neoplasms; Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dr. Amandine BRUYAS, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Amandine BRUYAS, MD, PhD

CONTACT

+33 4.78.86.16.28; amandine.bruyas@chu-lyon.fr

Irina-Elena ANTOCHI, Project manager

CONTACT

+33 4.78.86.43.22; irina-elena.antochi@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 13, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

FR (2)