SOMESThesia and ALIMentation

NCT ID: NCT05272917

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2023-04-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

head and neck cancer patients with radiotherapy AND chemotherapy

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

Group Type: EXPERIMENTAL

Sensorial tests

Intervention Type: 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.

food preferences questionnaires

Intervention Type: 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 only

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

Group Type: EXPERIMENTAL

Sensorial tests

Intervention Type: 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.

food preferences questionnaires

Intervention Type: 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.

healthy volunteers

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

Group Type: ACTIVE_COMPARATOR

Sensorial tests

Intervention Type: 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.

food preferences questionnaires

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amandine BRUYAS

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Centre de recherche de l'Institut Paul Bocuse

Écully, , France

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

Lyon, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37828382 (View on PubMed)

Other Identifiers

69HCL21_1153

Identifier Type: -

Identifier Source: org_study_id