Oncology, Undernutrition and Sensoriality: Links, Mechanisms and Levers for Action (ONDES)

February 17, 2026 updated by: Centre Hospitalier Universitaire Dijon

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 (Huang 2022). 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) (Globocan 2020). Patients with these two types of cancer are at particularly high risk of undernutrition (Pressoir 2010; Gyan 2018).

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 (Pressoir 2010). 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 (INCa 2014). 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) (De Conno 1989; Heckel 2015; Spotten 2017; van Oort 2018). The mechanisms involved in sensory changes are not fully understood, especially in cancer, and with different types and treatments (Murtaza 2017). Several hypotheses have been proposed: altered expression of enzymes of the oral sphere, altered expression of sensory receptors (Neiers 2021), saliva composition and function (Zhu 2021), and impact of the oral microbiota (Schwartz 2021a, Licandro 2023).

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible patients will be identified :

  • at the department's multidisciplinary consultation meetings
  • during consultations with their referring doctor (ENT or gastroenterologist)

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with cancer of the oral cavity/oropharynx
115 patients with cancer of the oral cavity/oropharynx
Other: tests/questionnaires
EVA, LFPQ-fr, Taste strips, ETOC 6-items, CiTAS, Fr-sQOD, WHOQOL-Bref, HADS
Biological: biological samples
blood, saliva, tongue mucus
Other: evaluation
strength tests using handgrip tests, chair lifts or walking speed and sarcopenia tests for the over-70s
colon cancer patients
123 colon cancer patients
Other: tests/questionnaires
EVA, LFPQ-fr, Taste strips, ETOC 6-items, CiTAS, Fr-sQOD, WHOQOL-Bref, HADS
Biological: biological samples
blood, saliva, tongue mucus
Other: evaluation
strength tests using handgrip tests, chair lifts or walking speed and sarcopenia tests for the over-70s
patients with liver cancer
68 patients with liver cancer
Other: tests/questionnaires
EVA, LFPQ-fr, Taste strips, ETOC 6-items, CiTAS, Fr-sQOD, WHOQOL-Bref, HADS
Biological: biological samples
blood, saliva, tongue mucus
Other: evaluation
strength tests using handgrip tests, chair lifts or walking speed and sarcopenia tests for the over-70s

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The presence or absence of undernutrition
Time Frame: Through study completion, an average of 12 months
Through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COTTET INCa SHSESP 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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