Breast Cancer, Digestive Cancers, Ear Cancer, Gynecologic Cancer, Lung Cancer, Nose Cancer, Throat Cancer
Conditions
Keywords
Cancer, nutrition, somesthesia, food, perceptions
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.
Interventions
OTHERSalivary 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.
OTHERFood 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.
OTHERQuestionnaires
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.
OTHERsensory 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.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Contacts
Primary ContactDr. Amandine BRUYAS, MD, PhD
Backup ContactIrina-Elena ANTOCHI, Project manager
Outcome results
None listed