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Recruiting NCT07632560

CANUT Junior : Assessment of Sensory Abilities and Eating Behavior in Pediatric Oncology: a Feasibility Study

Conditions: Pediatric Hematologic Malignancies, Pediatric Oncology

Sex: All
Ages: 7 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Centre Leon Berard

Location: Institut d'Hématologie et d'Oncologie Pédiatrique Lyon

Summary

Cancer treatments in children are very intense and often cause side effects such as nausea, vomiting, loss of appetite, and changes in taste and smell. These sensory alterations can impact eating habits, but they are still poorly understood in children. The study aims to assess whether it is feasible to measure these sensory changes (taste, smell, salivation, and food preferences) in children and adolescents undergoing cancer treatment. This study is a feasibility study with 30 patients aged 7 to 17 years, treated at the Pediatric Hematology and Oncology Institute (IHOPE) in Lyon. Sensory tests and questionnaires to evaluate the perceptions, oral health, eating habits, nutritional status, and quality of life are used. The inclusion was initially planned at diagnosis, before any administration of chemotherapy. However, the study quickly encountered a recruitment problem due to the emotional impact and medical burden of this initial period of care (study offered to 11 families over a period of 5 months, 3 patients included). An amendment to the protocol was therefore made to be able to modify the inclusion period after the completion of chemotherapy. This modification was implemented on May 15, 2025, and allowed the inclusion of two new patients, making a total of 5 patients. Of these 5 patients, two completed all the tests during V0 and V1, two completed V0 but not V1, one did not complete any of the visits. This feasibility phase will help determine whether the tools are suitable and well accepted. The results will be used to design a larger study aimed at better understanding how taste and smell alterations influence the eating behaviors of young patients during cancer treatment. Recruitment will continue for six more months in order to reach the target number of participants.

Eligibility Criteria

Inclusion Criteria: * Patients treated at a pediatric oncology-hematology center, with an initial diagnosis of a solid or hematological tumor, aged 7 to 17 years inclusive. * Patients with functional oral feeding * Parent/guardian who has signed the informed consent form and patient who has not expressed refusal * Patients affiliated with the social security system * French-speaking patients * Validated indication for systematic oncological treatment Exclusion Criteria: * Individuals with a known food allergy/intolerance to the prototypes being studied (does not apply to patients on a protected diet) * Individuals who have undergone surgery on the tongue * Patients for whom other types of cancer treatment are planned during the study period (e.g., radiation therapy) * Patients with dental conditions * Patients who have relapsed

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07632560). StuddyBuddy aggregates publicly available trial information.