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SOMESThesia and ALIMentation (SOMEST'ALIM)

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Sensorial tests

food preferences questionnaires

About this trial

This is an interventional basic science trial for Head and Neck Cancer focused on measuring head and neck cancer, nutrition, somesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Service d'Oncologie médicale, Hôpital de la Croix-Rousse
Centre de recherche de l'Institut Paul Bocuse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

head and neck cancer patients with radiotherapy AND chemotherapy

head and neck cancer patients with radiotherapy only

healthy volunteers

Arm Description

patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) + chemotherapy

patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) without chemotherapy

healthy volunteers paired with experimental patients on age (+/- 5 years), gender, tobacco status

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05272917

First Posted

February 14, 2022

Last Updated

October 9, 2023

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT05272917

Brief Title

SOMESThesia and ALIMentation

Acronym

SOMEST'ALIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

May 20, 2022 (Actual)

Primary Completion Date

April 14, 2023 (Actual)

Study Completion Date

April 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

head and neck cancer, nutrition, somesthesia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

head and neck cancer patients with radiotherapy AND chemotherapy

Arm Type

Experimental

Arm Description

patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) + chemotherapy

Arm Title

head and neck cancer patients with radiotherapy only

Arm Type

Experimental

Arm Description

patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) without chemotherapy

Arm Title

healthy volunteers

Arm Type

Active Comparator

Arm Description

healthy volunteers paired with experimental patients on age (+/- 5 years), gender, tobacco status

Intervention Type

Other

Intervention Name(s)

Sensorial tests

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

food preferences questionnaires

Intervention Description

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.

Primary Outcome Measure Information:

Title

Oral tactile sensitivity score

Description

Time Frame

Up to 3 months after recruitment.

Secondary Outcome Measure Information:

Title

thermic sensitivity score

Description

Time Frame

Up to 3 months after recruitment.

Title

trigeminal sensitivity score

Description

Time Frame

Up to 3 months after inclusion.

Title

texture sensitivity score

Description

Time Frame

Up to 3 months after recruitment.

Title

salivary function

Description

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.

Time Frame

Up to 3 months after recruitment.

Title

food preference score

Description

Time Frame

Up to 3 months after recruitment.

Title

sensory perception, dietary habits and oral health

Description

Time Frame

Up to 3 months after recruitment.

Title

correlation sensory perception and food preferences

Description

Time Frame

Up to 3 months after recruitment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amandine BRUYAS

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service d'Oncologie médicale, Hôpital de la Croix-Rousse

City

Lyon

ZIP/Postal Code

69004

Country

France

Facility Name

Centre de recherche de l'Institut Paul Bocuse

City

Écully

ZIP/Postal Code

69131

Country

France

12. IPD Sharing Statement

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