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Recruiting Observational

Oncology, Undernutrition and Sensoriality: Links, Mechanisms and Levers for Action

NCT06600295 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-09-06
Last updated
2026-10-08

Condition(s) studied

Oropharynx CancerOral CavityColon CancerLiver Cancer

Investigational drug(s) / intervention(s)

tests/questionnairesbiological samples →evaluation

tests/questionnaires: EVA, LFPQ-fr, Taste strips, ETOC 6-items, CiTAS, Fr-sQOD, WHOQOL-Bref, HADS

biological samples: blood, saliva, tongue mucus

evaluation: strength tests using handgrip tests, chair lifts or walking speed and sarcopenia tests for the over-70s

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The presence or absence of undernutrition — Through study completion, an average of 12 months

Trial sites (1)

FacilityCityRegionStatus
Chu Dijon Bourgogne Dijon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06600295 on ClinicalTrials.gov ↗ ← All trials in France