Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHospices Civils de Lyon

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Salivary test

    Other intervention

    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.

  • Food tasting

    Other intervention

    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.

  • Questionnaires

    Other intervention

    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.

  • sensory capacity evaluation

    Other intervention

    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.

Treatment groups

96 Participants
are divided into 1 treatment group
Group A: Patients with cancer and under treatment from at least two months.4 interventions

Trial outcomes

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).

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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