SOMESThesia and ALIMentation

NCT05272917 | Completed

• 1 other identifier: 69HCL21_1153
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancers

Keywords

Head and Neck cancers; nutrition; somesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• thermic sensitivity score

  Up to 3 months after recruitment.

• trigeminal sensitivity score

  Up to 3 months after inclusion.

• texture sensitivity score

  Up to 3 months after recruitment.

• salivary function

  Up to 3 months after recruitment.

• food preference score

  Up to 3 months after recruitment.

Study Arms (3)

head and neck cancer patients with radiotherapy AND chemotherapy

EXPERIMENTAL

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

Other: Sensorial tests; Behavioral: food preferences questionnaires

head and neck cancer patients with radiotherapy only

EXPERIMENTAL

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

Other: Sensorial tests; Behavioral: food preferences questionnaires

healthy volunteers

ACTIVE COMPARATOR

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

Other: Sensorial tests; Behavioral: food preferences questionnaires

Interventions

Sensorial tests OTHER

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.

head and neck cancer patients with radiotherapy AND chemotherapy; head and neck cancer patients with radiotherapy only; healthy volunteers

food preferences questionnaires BEHAVIORAL

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.

head and neck cancer patients with radiotherapy AND chemotherapy; head and neck cancer patients with radiotherapy only; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 with no current treatment that may affect taste and smell perception

You may not qualify if:

• 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 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:

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Centre de recherche de l'Institut Paul Bocuse

Écully, 69131, France

Location

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

Lyon, 69004, France

Location

Related Publications (1)

• Riantiningtyas RR, Valenti A, Dougkas A, Bredie WLP, Kwiecien C, Bruyas A, Giboreau A, Carrouel F. Oral somatosensory alterations and salivary dysfunction in head and neck cancer patients. Support Care Cancer. 2023 Oct 13;31(12):627. doi: 10.1007/s00520-023-08086-7.

  PMID: 37828382 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Amandine BRUYAS

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: May 20, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)