Clinical trial NCT05272917: SOMESThesia and ALIMentation
Official title: SOMESThesia in Patients With Head and Neck Cancer: Variability and Influence on the ALIMentation Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
nutrition
somesthesia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Oral tactile sensitivity score
timeFrame: Up to 3 months after recruitment.
Secondary outcomes:
measure: thermic sensitivity score
timeFrame: Up to 3 months after recruitment.
measure: trigeminal sensitivity score
timeFrame: Up to 3 months after inclusion.
measure: texture sensitivity score
timeFrame: Up to 3 months after recruitment.
measure: salivary function
timeFrame: Up to 3 months after recruitment.
measure: food preference score
timeFrame: Up to 3 months after recruitment.
measure: sensory perception, dietary habits and oral health
timeFrame: Up to 3 months after recruitment.
measure: correlation sensory perception and food preferences
timeFrame: Up to 3 months after recruitment.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'Oncologie médicale, Hôpital de la Croix-Rousse
city: Écully
country: France
facility: Centre de recherche de l'Institut Paul Bocuse
Study officials:
affiliation: Hospices Civils de Lyon
name: Amandine BRUYAS
role: PRINCIPAL_INVESTIGATOR
References: