Head and Neck CancersSOMEST'ALIMNCT05272917
SOMESThesia and ALIMentation
A study testing Sensorial tests and food preferences questionnaires in people with Head and Neck Cancers, run by Hospices Civils de Lyon at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Sensorial tests and food preferences questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 20 May 2022to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de recherche de l'Institut Paul Bocuse
Écully, 69131
Service d'Oncologie médicale, Hôpital de la Croix-Rousse
Lyon, 69004
About this study
Official title: SOMESThesia in Patients With Head and Neck Cancer: Variability and Influence on the ALIMentation Experience
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).
Read more
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
- Being tested
- Sensorial tests, food preferences questionnaires
- Keywords
- Head and Neck cancers, nutrition, somesthesia
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorial testsOther
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 questionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| head and neck cancer patients with radiotherapy AND chemotherapy | Experimental | patients included for a head and neck cancer and treated by radiotherapy (+/- surgery) + chemotherapy Receives: 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 Receives: Other: Sensorial tests; Behavioral: food preferences questionnaires |
| healthy volunteers | Active comparator | healthy volunteers paired with experimental patients on age (+/- 5 years), gender, tobacco status Receives: Other: Sensorial tests; Behavioral: food preferences questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months after recruitment.
Secondary outcomes (7)
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.
Measured: Up to 3 months after recruitment.
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.
Measured: Up to 3 months after inclusion.
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.
Measured: Up to 3 months after recruitment.
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.
Measured: Up to 3 months after recruitment.
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.
Measured: Up to 3 months after recruitment.
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.
Measured: Up to 3 months after recruitment.
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.
Measured: Up to 3 months after recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start20 May 2022
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine BRUYAS, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272917
- Sponsor's protocol ID
- 69HCL21_1153
- Acronym
- SOMEST'ALIM
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37828382
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOMESThesia in Patients With Head and Neck Cancer: Variability and Influence on the ALIMentation Experience
- ClinicalTrials.gov ID
- NCT05272917
- Acronym / sponsor ID
- SOMEST'ALIM / 69HCL21_1153
- Conditions
- Head and Neck Cancers
- Keywords
- Head and Neck cancers, nutrition, somesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| head and neck cancer patients with radiotherapy AND chemotherapy | Experimental | Other: Sensorial tests, Behavioral: food preferences questionnairespatients included for a head and neck cancer and treated by radiotherapy (+/- surgery) + chemotherapy |
| head and neck cancer patients with radiotherapy only | Experimental | Other: Sensorial tests, Behavioral: food preferences questionnairespatients included for a head and neck cancer and treated by radiotherapy (+/- surgery) without chemotherapy |
| healthy volunteers | Active comparator | Other: Sensorial tests, Behavioral: food preferences questionnaireshealthy volunteers paired with experimental patients on age (+/- 5 years), gender, tobacco status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorial testsPatients 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. | Other | head and neck cancer patients with radiotherapy AND chemotherapy, head and neck cancer patients with radiotherapy only, healthy volunteers |
| food preferences questionnairesPatients 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. | Behavioural | head and neck cancer patients with radiotherapy AND chemotherapy, head and neck cancer patients with radiotherapy only, healthy volunteers |
Primary outcome
Oral tactile sensitivity score
Time frame: Up to 3 months after recruitment.
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.
7 secondary outcomes
thermic sensitivity score
Time frame: Up to 3 months after recruitment.
trigeminal sensitivity score
Time frame: Up to 3 months after inclusion.
texture sensitivity score
Time frame: Up to 3 months after recruitment.
salivary function
Time frame: Up to 3 months after recruitment.
food preference score
Time frame: Up to 3 months after recruitment.
sensory perception, dietary habits and oral health
Time frame: Up to 3 months after recruitment.
correlation sensory perception and food preferences
Time frame: Up to 3 months after recruitment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 37828382Riantiningtyas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine BRUYAS principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorial tests and food preferences questionnaires in people with Head and Neck Cancers, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral tactile sensitivity score (time frame: Up to 3 months after recruitment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.