About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with different types of cancer: digestive, breast, gynecologic, ENT, lung and aged between 18 and 70 years.
Trial design
Cohort
Prospective
Treatments tested in this trial
Salivary test
Other interventionIn 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.
Food tasting
Other interventionPatients 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.
Questionnaires
Other interventionPatients 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.
sensory capacity evaluation
Other interventionFor 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Sponsors and contacts
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