SOMESThesia and ALIMentation

Head and Neck Cancer Clinical Trial

— SOMEST'ALIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05272917
• Other study ID #: 69HCL21_1153
• Status: Completed
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Sensorial tests
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.

Behavioral:
• food preferences questionnaires
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.

Locations

Country	Name	City	State
France	Centre de recherche de l'Institut Paul Bocuse	Écully
France	Service d'Oncologie médicale, Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.