Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
NCT ID: NCT06803381
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
96 participants
OBSERVATIONAL
2025-03-13
2025-06-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Salivary 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.
Food 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.
Questionnaires
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
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.
Interventions
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Salivary 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.
Food 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.
Questionnaires
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
70 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Dr. Amandine BRUYAS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot
Lyon, , France
Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A02687-40
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL24_0539
Identifier Type: -
Identifier Source: org_study_id
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