Digestive CancersSOMEST'ALIM2NCT06803381
Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
An observational study of Digestive Cancers and Breast Cancer, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Digestive Cancers, Breast Cancer, Gynecologic Cancer
- What is being tested?
- Salivary test, Food tasting and Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 96 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Mar 2025to 15 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with different types of cancer: digestive, breast, gynecologic, ENT, lung and aged between 18 and 70 years.
Who may be able to join
- Patient between 18 and 70 years old
- Patient with digestive, breast, gynecologic, ENT or lung cancer
- Patient receiving a cancer treatment from at least two months
- Patient having given his free, informed and express written consent
Who cannot join
- Patient having a radiotherapy treatment for an ENT cancer
- Patient with a known food allergy/intolerance to food samples (which may contain dairy products)
- Patient unable to swallow soft food
- Patient having presented nausea and vomiting during the last 24 hours
- Patient with severe inflammation of the mouth or throat (ulcers, mucus)
- Patient with cognitive disorders and memory loss
- Pregnant women or breastfeeding
- Adult under legal protection (guardianship)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot
Lyon, 69003
Patrick ROBELIN, MD, PhD, +33 4.72.11.26.60, patrick.robelin@chu-lyon.fr
Patrick ROBELIN, MD, PhD
Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse
Lyon, 69004
Amandine BRUYAS, MD, PhD, +33 4.78.86.16.28, amandine.bruyas@chu-lyon.fr
Amandine BRUYAS, MD, PhD
About this study
Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life.
Cancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients.
Read more
SOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version.
Patients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire.
In a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.
- Conditions
- Digestive Cancers, Breast Cancer, Gynecologic Cancer, Lung Cancer, Nose Cancer, Throat Cancer
- Being tested
- Salivary test, Food tasting, Questionnaires, sensory capacity evaluation
- Keywords
- Cancer, nutrition, somesthesia, food, perceptions
- Medical subject headings
- Gastrointestinal Neoplasms, Breast Neoplasms, Lung Neoplasms, Nose Neoplasms, Ear Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary testOther
In order to determine the quantity and quality of patients saliva before food tasting a saliva test will be performed using a Saliva-Check BUFFER kit. A small quantity of saliva will be collected and discarded immediately after the test result obtained.
The test will be done only once for each patient.
Food tastingOther
Patients will be invited to taste four different food samples, 2 sweet and 2 salty samples, and to evaluate them using a visual analog scale (0 : I don't like at all to 100 : I like a lot). The intervention will be done once for each patient during one of their standard of care treatment visit.
QuestionnairesOther
Patients will be invited to answer to some questionnaires : socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, QLQ-C30 quality of life and food quality of life questionnaire. They will answer to all questionnaires only once during participation to the study.
sensory capacity evaluationOther
For the sensory capacity the test 6-n-propylthiouracil (PROP) taste strip will be used. One tasting strip will be placed on the tongue and patients will be asked to assess the intensity of bitterness.
The test will be done only once for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer and under treatment from at least two months. | The study will involve adult subjects with different types of cancer (digestive, gynecological, breast, ENT, lung) receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing ENT radiotherapy) in a standard of care program. Patients participating to the trial will perform a salivary test, an evaluation of the sensory capacity, food tasting and will answer to different questionnaires Receives: Other: Salivary test; Other: Food tasting; Other: Questionnaires; Other: sensory capacity evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS) score
The score difference of a visual analogue scale (VAS) (0 : I don't like at all to 100 : I like a lot) will be used to evaluate perception of patients with cancer on two different versions of food. The scale unit will be in mm and the difference in VAS score between the two food categories will be compared (hedonic delta).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start13 Mar 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Amandine BRUYAS, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803381
- Sponsor's protocol ID
- 69HCL24_0539
- Other IDs
- 2024-A02687-40
- Acronym
- SOMEST'ALIM2
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
- ClinicalTrials.gov ID
- NCT06803381
- Acronym / sponsor ID
- SOMEST'ALIM2 / 69HCL24_0539
- Conditions
- Digestive Cancers, Breast Cancer, Gynecologic Cancer, Lung Cancer, Nose Cancer, Throat Cancer
- Keywords
- Cancer, nutrition, somesthesia, food, perceptions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Mar 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life.
Cancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients.
SOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version.
Patients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire.
In a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer and under treatment from at least two months. | – | Other: Salivary test, Other: Food tasting, Other: Questionnaires, Other: sensory capacity evaluationThe study will involve adult subjects with different types of cancer (digestive, gynecological, breast, ENT, lung) receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing ENT radiotherapy) in a standard of care program. Patients participating to the trial will perform a salivary test, an evaluation of the sensory capacity, food tasting and will answer to different questionnaires |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different types of cancer: digestive, breast, gynecologic, ENT, lung and aged between 18 and 70 years.
Key inclusion criteria (4 listed)
- Patient between 18 and 70 years old
- Patient with digestive, breast, gynecologic, ENT or lung cancer
- Patient receiving a cancer treatment from at least two months
- Patient having given his free, informed and express written consent
Key exclusion criteria (8 listed)
- Patient having a radiotherapy treatment for an ENT cancer
- Patient with a known food allergy/intolerance to food samples (which may contain dairy products)
- Patient unable to swallow soft food
- Patient having presented nausea and vomiting during the last 24 hours
- Patient with severe inflammation of the mouth or throat (ulcers, mucus)
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 |
|---|---|---|
| Salivary testIn order to determine the quantity and quality of patients saliva before food tasting a saliva test will be performed using a Saliva-Check BUFFER kit. A small quantity of saliva will be collected and discarded immediately after the test result obtained. The test will be done only once for each patient. | Other | Patients with cancer and under treatment from at least two months. |
| Food tastingPatients will be invited to taste four different food samples, 2 sweet and 2 salty samples, and to evaluate them using a visual analog scale (0 : I don't like at all to 100 : I like a lot). The intervention will be done once for each patient during one of their standard of care treatment visit. | Other | Patients with cancer and under treatment from at least two months. |
| QuestionnairesPatients will be invited to answer to some questionnaires : socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, QLQ-C30 quality of life and food quality of life questionnaire. They will answer to all questionnaires only once during participation to the study. | Other | Patients with cancer and under treatment from at least two months. |
| sensory capacity evaluationFor the sensory capacity the test 6-n-propylthiouracil (PROP) taste strip will be used. One tasting strip will be placed on the tongue and patients will be asked to assess the intensity of bitterness. The test will be done only once for each patient. | Other | Patients with cancer and under treatment from at least two months. |
Primary outcome
visual analogue scale (VAS) score
Time frame: Day 1
The score difference of a visual analogue scale (VAS) (0 : I don't like at all to 100 : I like a lot) will be used to evaluate perception of patients with cancer on two different versions of food. The scale unit will be in mm and the difference in VAS score between the two food categories will be compared (hedonic delta).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dr. Amandine BRUYAS, MD, PhD 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?
An observational study of Digestive Cancers and Breast Cancer, 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Amandine BRUYAS, MD, PhD (+33 4.78.86.16.28, amandine.bruyas@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.