AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
  • Chu Dijon Bourgogne

    Dijon, 21000

    Vanessa COTTET, 0380393487 ext. +33, Vanessa.cottet@u-bourgogne.fr

    Recruiting

Other trials in France

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.

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 groups in NCT06600295
Study groupRoleWhat they receive
patients with cancer of the oral cavity/oropharynx115 patients with cancer of the oral cavity/oropharynx
Receives: Other: tests/questionnaires; Biological: biological samples; Other: evaluation
colon cancer patients123 colon cancer patients
Receives: Other: tests/questionnaires; Biological: biological samples; Other: evaluation
patients with liver cancer68 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.

  1. 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.

  1. First posted19 Sep 2024
  2. Study start6 Sep 2024
  3. Primary completionSep 2031 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in