Oropharynx CancerONDESNCT06600295
Oncology, Undernutrition and Sensoriality: Links, Mechanisms and Levers for Action
An observational study of Oropharynx Cancer and Oral Cavity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cancers of the upper aerodigestive tract account for around 4% of all malignant tumours worldwide. Colon and liver cancer are the most common digestive cancers. The epidemiology of liver cancer is changing, and the number of deaths from liver cancer has increased by 25% worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer, Oral Cavity, Colon Cancer
- What is being tested?
- tests/questionnaires, biological samples and evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2024to Sep 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be identified : * at the department\'s multidisciplinary consultation meetings * during consultations with their referring doctor (ENT or gastroenterologist)
Who may be able to join
- Patient :
- With newly diagnosed cancer of the oropharynx, oral cavity, colon or liver (at any stage).
- For whom first-line treatment has been decided including radiotherapy, chemotherapy, immunotherapy and/or surgery.
- Able to follow all study procedures in accordance with the protocol.
- Have given their oral, free and informed consent to participate in the study.
Who cannot join
- Person not affiliated with national health insurance system
- Person subject to a legal protection measure (curatorship, guardianship)
- Pregnant women, women in labour or breastfeeding mothers
- Adults who is unable to give consent
- Minors
- Person unable to read, speak, write and understand French
Show all 14Show fewer
- Patients with neuro-cognitive disorders (post-stroke, dyslexia, dyspraxia) or neuro-psychiatric disorders (dementia, autism) that make it impossible to assess taste sensoriality.
- Patients with olfactory or gustatory disorders documented prior to the disease
- Patient with another cancer currently being treated
- Patients with a systemic disease or physical trauma affecting taste perception
- Patients with kidney failure
- Patients with sinonasal polyposis
- Patients undergoing immunosuppressive treatment
- Patients with an estimated life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Vanessa COTTET, 0380393487 ext. +33, Vanessa.cottet@u-bourgogne.fr
About this study
Official title: Oncology, Undernutrition and Sensoriality: Links, Mechanisms and Levers for Action - Study ONDES
Cancers of the upper aerodigestive tract account for around 4% of all malignant tumours worldwide. Colon and liver cancer are the most common digestive cancers. The epidemiology of liver cancer is changing, and the number of deaths from liver cancer has increased by 25% worldwide. In France, around 19,000 cancers of the upper aerodigestive tract and 88,000 new cases of digestive cancer are diagnosed each year (colon cancer remains the most common). Patients with these two types of cancer are at particularly high risk of undernutrition.
In cancer patients, changes in diet may result from constraints linked to the cancer or possible after-effects, but also from personal choices (for example, adopting a healthier diet). Cancer and its treatment lead to changes such as increased nutritional requirements and hypercatabolism, or sensory changes (taste and smell), reducing pleasure and food intake. These problems will impair quality of life and intensify undernutrition, a major problem in the management of the disease since it increases the risk of complications, therapeutic failure and mortality. It is estimated that 10-20% of deaths in cancer patients are attributable to the consequences of undernutrition rather than to the disease itself. In the VICAN study, 41% of patients changed their diet after diagnosis: 29% because of changes in taste and 82% to have a healthier diet. These changes were associated with the treatment received, the presence of sequelae and anxiety.
Read more
Taste and smell disorders are common in different types of cancer (any solid or haematological type) and treatments (chemotherapy, radiotherapy and surgery. The mechanisms involved in sensory changes are not fully understood, especially in cancer, and with different types and treatments. Several hypotheses have been proposed: altered expression of enzymes of the oral sphere, altered expression of sensory receptors, saliva composition and function, and impact of the oral microbiota.
The early identification of undesirable effects linked to nutrition, and the early or anticipated diagnosis of undernutrition are important issues in the management of cancer patients. The pleasure (or displeasure) produced by food guides desire and eating behaviour. The mechanisms involved are linked to hedonic sensations: conditioned satiety, specific sensory satiety, negative alliesthesia and the reward system (hedonic system). The latter is influenced by the environment and can be consciously controlled, with several dimensions: liking (the patient likes or dislikes a given food) and wanting (evaluates the desire to consume a given food at a given moment). All these parameters, together with sensory and dietary learning throughout life (habits, beliefs and constraints), influence food preferences and therefore eating behaviour. Individual sensitivities and the personal history of the disease (treatment and care pathway, sequelae, presence of co-morbidities, etc.) must therefore be taken into account when setting up preventive actions for cancer patients. It seems important to explore these factors, the experience of patients and the consequences for eating behaviour in daily life, in order to improve support and communication with healthcare professionals, as well as prevention and early detection of undernutrition. It would be interesting to conduct more in-depth studies on nutritional status, quality of life and changes in taste and smell, which in most studies have been considered separately.
- Conditions
- Oropharynx Cancer, Oral Cavity, Colon Cancer, Liver Cancer
- Being tested
- tests/questionnaires, biological samples, evaluation
- Medical subject headings
- Oropharyngeal Neoplasms, Colonic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tests/questionnairesOther
EVA, LFPQ-fr, Taste strips, ETOC 6-items, CiTAS, Fr-sQOD, WHOQOL-Bref, HADS
biological samplesBiological
blood, saliva, tongue mucus
evaluationOther
strength tests using handgrip tests, chair lifts or walking speed and sarcopenia tests for the over-70s
| Study group | Role | What they receive |
|---|---|---|
| patients with cancer of the oral cavity/oropharynx | 115 patients with cancer of the oral cavity/oropharynx Receives: Other: tests/questionnaires; Biological: biological samples; Other: evaluation | |
| colon cancer patients | 123 colon cancer patients Receives: Other: tests/questionnaires; Biological: biological samples; Other: evaluation | |
| patients with liver cancer | 68 patients with liver cancer Receives: Other: tests/questionnaires; Biological: biological samples; Other: evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of undernutrition
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Sep 2024
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- 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
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600295
- Sponsor's protocol ID
- COTTET INCa SHSESP 2023
- Acronym
- ONDES
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncology, Undernutrition and Sensoriality: Links, Mechanisms and Levers for Action - Study ONDES
- ClinicalTrials.gov ID
- NCT06600295
- Acronym / sponsor ID
- ONDES / COTTET INCa SHSESP 2023
- Conditions
- Oropharynx Cancer, Oral Cavity, Colon Cancer, Liver Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 19 Sep 2024 (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.
Cancers of the upper aerodigestive tract account for around 4% of all malignant tumours worldwide. Colon and liver cancer are the most common digestive cancers. The epidemiology of liver cancer is changing, and the number of deaths from liver cancer has increased by 25% worldwide. In France, around 19,000 cancers of the upper aerodigestive tract and 88,000 new cases of digestive cancer are diagnosed each year (colon cancer remains the most common). Patients with these two types of cancer are at particularly high risk of undernutrition.
In cancer patients, changes in diet may result from constraints linked to the cancer or possible after-effects, but also from personal choices (for example, adopting a healthier diet). Cancer and its treatment lead to changes such as increased nutritional requirements and hypercatabolism, or sensory changes (taste and smell), reducing pleasure and food intake. These problems will impair quality of life and intensify undernutrition, a major problem in the management of the disease since it increases the risk of complications, therapeutic failure and mortality. It is estimated that 10-20% of deaths in cancer patients are attributable to the consequences of undernutrition rather than to the disease itself. In the VICAN study, 41% of patients changed their diet after diagnosis: 29% because of changes in taste and 82% to have a healthier diet. These changes were associated with the treatment received, the presence of sequelae and anxiety.
Taste and smell disorders are common in different types of cancer (any solid or haematological type) and treatments (chemotherapy, radiotherapy and surgery. The mechanisms involved in sensory changes are not fully understood, especially in cancer, and with different types and treatments. Several hypotheses have been proposed: altered expression of enzymes of the oral sphere, altered expression of sensory receptors, saliva composition and function, and impact of the oral microbiota.
The early identification of undesirable effects linked to nutrition, and the early or anticipated diagnosis of undernutrition are important issues in the management of cancer patients. The pleasure (or displeasure) produced by food guides desire and eating behaviour. The mechanisms involved are linked to hedonic sensations: conditioned satiety, specific sensory satiety, negative alliesthesia and the reward system (hedonic system). The latter is influenced by the environment and can be consciously controlled, with several dimensions: liking (the patient likes or dislikes a given food) and wanting (evaluates the desire to consume a given food at a given moment). All these parameters, together with sensory and dietary learning throughout life (habits, beliefs and constraints), influence food preferences and therefore eating behaviour. Individual sensitivities and the personal history of the disease (treatment and care pathway, sequelae, presence of co-morbidities, etc.) must therefore be taken into account when setting up preventive actions for cancer patients. It seems important to explore these factors, the experience of patients and the consequences for eating behaviour in daily life, in order to improve support and communication with healthcare professionals, as well as prevention and early detection of undernutrition. It would be interesting to conduct more in-depth studies on nutritional status, quality of life and changes in taste and smell, which in most studies have been considered separately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with cancer of the oral cavity/oropharynx | – | Other: tests/questionnaires, Biological: biological samples, Other: evaluation115 patients with cancer of the oral cavity/oropharynx |
| colon cancer patients | – | Other: tests/questionnaires, Biological: biological samples, Other: evaluation123 colon cancer patients |
| patients with liver cancer | – | Other: tests/questionnaires, Biological: biological samples, Other: evaluation68 patients with liver cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be identified : * at the department\'s multidisciplinary consultation meetings * during consultations with their referring doctor (ENT or gastroenterologist)
Key inclusion criteria (5 listed)
- With newly diagnosed cancer of the oropharynx, oral cavity, colon or liver (at any stage).
- For whom first-line treatment has been decided including radiotherapy, chemotherapy, immunotherapy and/or surgery.
- Able to follow all study procedures in accordance with the protocol.
- Have given their oral, free and informed consent to participate in the study.
Key exclusion criteria (14 listed)
- Person not affiliated with national health insurance system
- Person subject to a legal protection measure (curatorship, guardianship)
- Pregnant women, women in labour or breastfeeding mothers
- Adults who is unable to give consent
- Minors
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 |
|---|---|---|
| tests/questionnairesEVA, LFPQ-fr, Taste strips, ETOC 6-items, CiTAS, Fr-sQOD, WHOQOL-Bref, HADS | Other | colon cancer patients, patients with cancer of the oral cavity/oropharynx, patients with liver cancer |
| biological samplesblood, saliva, tongue mucus | Biological | colon cancer patients, patients with cancer of the oral cavity/oropharynx, patients with liver cancer |
| evaluationstrength tests using handgrip tests, chair lifts or walking speed and sarcopenia tests for the over-70s | Other | colon cancer patients, patients with cancer of the oral cavity/oropharynx, patients with liver cancer |
Primary outcome
The presence or absence of undernutrition
Time frame: Through study completion, an average of 12 months
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 8 Oct 2026.
Related trials for Oropharynx Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 3
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharynx Cancer and Oral Cavity, run by Centre Hospitalier Universitaire Dijon at 1 site 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Vanessa COTTET (0380393487 ext. +33, Vanessa.cottet@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence or absence of undernutrition (time frame: Through study completion, an average of 12 months). 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 8 Oct 2026.