SOMESThesia and ALIMentation

Study Overview
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Brief Summary
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Cancer patients are at high risk for undernutrition. A study with head and neck cancer patients showed that 50% suffered from undernutrition (Prevost et al., 2014). Sensory alterations may also involve sensory changes from the physiological structures of the mouth or neural pathways and hedonic changes, i.e., although food may taste the same as usual, that taste is no longer judged as pleasant. These changes lead to an aversion to food and a decrease in the pleasure of eating (Bernhardson et al., 2009). Despite the large number of published studies on taste and smell alterations in diverse cancer populations, few have examined other dimensions of oral sensory alterations. Studies focusing on somesthesia have mostly been conducted in the area of oral physiology or stomatology in relation to oral pain and rehabilitation (Howes, Wongsriruksa, Laughlin, Witchel, & Miodownik, 2014). Regarding food perception, somesthesia provides information about both texture, temperature, and trigeminal sensations. These sensations are detected by mechanical, thermal, nociceptive receptors present throughout the oral epithelium (Simons & Carstens, 2008). In addition to taste and smell, food perception is influenced by oral somatosensation and studies have demonstrated an interrelated relationship between these oral sensations (Spence, Piqueras-Fiszman 2016). Therefore, ther might have a correlation between oral somatosensation and food preferences, subsequently influencing eating behavior and food consumption. A standard method, using a so-called Von Frey Hair monofilament, to assess tactile sensation was developed by Etter et al. (Etter, N. M et al.,. J. Vis. Exp. 2020) but has so far been only minimally used in Ear, Nose and Throat (ENT) cancer (Bearelly, Wang, & Cheung, 2017; Bodin, Jäghagen, & Isberg, 2004; Elfring, Boliek, Seikaly, Harris, & Rieger, 2012). The aim of the study is to determine the variability and role of somatosensory perception (texture, pungency transmitted through the trigeminal system, and temperature) on food preferences in cancer patients compared to healthy volunteers.

Official Title
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SOMESThesia in Patients With Head and Neck Cancer: Variability and Influence on the ALIMentation Experience

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Sensorial tests
* Behavioral: food preferences questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects: Person between 18 and 65 years Person having given free, informed, express written consent Person affiliated to a French social security system Person with a body mass superior to 18 kg/m². Person able to come once to the Institut Paul Bocuse Patients with head and neck cancer with chemotherapy: - Patient diagnosed with squamous cell head and neck cancer with the following treatment regimen: Surgery + radiochemotherapy or radiochemotherapy alone Patients with head and neck cancer without chemotherapy: - Patient diagnosed with squamous cell head and neck cancer with the following treatment regimen: Surgery + radiation therapy or radiation therapy alone Healthy volunteers : Volunteer who is +/- 5 years of age relative to the patient to whom they are matched. Volunteer of the same sex as the patient to whom they are matched Volunteer with the same smoking status as the patient to whom they are matched Volunteer who has not had cancer within 5 years at the time of inclusion Volunteer with no current treatment that may affect taste and smell perception Exclusion Criteria: All subjects: Person with a known food allergy/intolerance (lactose or milk protein) or unable to consume dairy or solid products (e.g., chocolate milk pudding, chocolate jelly) Person with a known allergy to chili (or capsaicin) Person with diagnosed total ageusia Person with diagnosed total anosmia Person who has used artificial feeding within 2 months prior to inclusion. Person who has lost more than 10% of baseline weight in the 2 months prior to inclusion Person deprived of liberty or under guardianship or trusteeship. Pregnant or breastfeeding woman Person deprived of liberty by a judicial or administrative decision Person under guardianship or protection of vulnerable adults Person with trismus (reduced jaw opening or limited jaw range of motion) A person who is unable to extend his or her tongue Person who has had surgery on the mobile tongue and/or base of the tongue Person unable to swallow soft foods Person who has had or is suspected of having had Corona Virus Disease (COVID)-19 within the last 6 months. Patients with head and neck cancer: Patient receiving immunotherapy Patient treated with surgery only.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: head and neck cancer patients with radiotherapy AND chemotherapy<br>patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) + chemotherapy | Other: Sensorial tests<br>* Patients will be included in the study between 3 to 6 months after the end of treatment and go to the Paul Bocuse Research Institute to perform several sensorial tests. The same sensorial tests will be completed by healthy volunteers to compare.<br>Behavioral: food preferences questionnaires<br>* Patients will be included in the study between 3 to 6 months after the end of treatment and go at Institut Paul Bocuse to complete food preferences questionnaires. The same questionnaires will be completed by healthy volunteers to compare.<br>|
| Experimental: head and neck cancer patients with radiotherapy only<br>patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) without chemotherapy | Other: Sensorial tests<br>* Patients will be included in the study between 3 to 6 months after the end of treatment and go to the Paul Bocuse Research Institute to perform several sensorial tests. The same sensorial tests will be completed by healthy volunteers to compare.<br>Behavioral: food preferences questionnaires<br>* Patients will be included in the study between 3 to 6 months after the end of treatment and go at Institut Paul Bocuse to complete food preferences questionnaires. The same questionnaires will be completed by healthy volunteers to compare.<br>|
| Active Comparator: healthy volunteers<br>healthy volunteers paired with experimental patients on age (+/- 5 years), gender, tobacco status | Other: Sensorial tests<br>* Patients will be included in the study between 3 to 6 months after the end of treatment and go to the Paul Bocuse Research Institute to perform several sensorial tests. The same sensorial tests will be completed by healthy volunteers to compare.<br>Behavioral: food preferences questionnaires<br>* Patients will be included in the study between 3 to 6 months after the end of treatment and go at Institut Paul Bocuse to complete food preferences questionnaires. The same questionnaires will be completed by healthy volunteers to compare.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral tactile sensitivity score | The primary endpoint of the study is to measure oral tactile sensitivity using the Von Frey Hair monofilament pressure test in head and neck cancer patients compared to healthy volunteers. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thermic sensitivity score | Measurement on a visual analog scale (gLMS) of sensitivity to heat and cold using dental mirrors. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 
| trigeminal sensitivity score | Visual analog scale (gLMS) measurement of trigeminal sensitivity using prepared solutions. This will be assessed at inclusion for healthy volunteers and between 1 to 3 months after inclusion for head and neck cancer patients. | Up to 3 months after inclusion. | 
| texture sensitivity score | Measurement of texture sensitivity (firmness, consistency, and roughness) on a visual analog scale (gLMS) from food samples. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 
| salivary function | Saliva function measurement with a BUFFER Saliva-check kit. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 
| food preference score | Measurement of food preference based on food pictures on a visual analog scale and according to the participant's ethnicity, family and social status. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 
| sensory perception, dietary habits and oral health | Measured by self-reported questionnaires of subjective sensory perception, dietary habits, and oral health and according to the participant's ethnicity, family and social status. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 
| correlation sensory perception and food preferences | Correlation analysis between sensory perception and food preferences for each participant. This will be assessed at recruitment for healthy volunteers and between 1 to 3 months after recruitment for head and neck cancer patients. | Up to 3 months after recruitment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, nutrition, somesthesia