CANUT Junior : Assessment of Sensory Abilities and Eating Behavior in Pediatric Oncology: a Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorCentre Leon Berard
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
tests
Diagnostic testThe measures that are taken are, olfactory and gustatory capacities, measurement of salivary quantity and quality, preference and acceptance of textures. We also assess the state of oral health, dietary habits and food consumption with questionnaires. Measurements of weight, height and BMI are taken, and nutritional status is assessed. The Easy Assessment Score of Ingesta is also used for an early diagnosis of the risk of malnutrition or undernutrition and finally the quality of life with the help of a questionnaire.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine the feasibility of testing olfactory, gustatory, and salivary function in children aged 7 to 17 years undergoing chemotherapy.
Completion rate: proportion of patients who complete all of the following tests in full at both measurement times. The tests will be considered feasible if at least 60% of patients complete all of the tests
Time frame
T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0Secondary outcomes
1
Correlation between impaired olfactory ability / impaired taste ability and: Sensitivity to texture /Texture preference / Food preferences and habits / Salivary function / Caloric intake / Nutritional status / Quality of life
evaluating the rate of patients presenting olfactory impairment (assessed by the Sniffin Sticks test) or taste impairment (assessed using taste strips) who are also presenting : * taste impairment, using the Taste Alteration Scale for Children with Cancer Receiving Chemotherapy questionnaires and the Gustonco questionnaire. * a modification of sensitivity to texture, measured on a 7-point smiley scale using food samples * a modification of food texture preference assessed using a questionnaire based on pictographic drawings. * a modification of food preferences and habits assessed using the Behavioral Pediatrics Feeding Assessment Scale * a modification of salivary function measured using a Saliva-check BUFFER kit. The daily calorie intake of every patient will be assessed using a 24-hour food diary, the nutritional status (weight in kg, height in cm, body mass index (BMI)and the quality of life will be assessed using the PedsQL questionnaire
Time frame
T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Leon Berard
Lead sponsor
Institut Lyfe
Collaborator
Source ClinicalTrials.gov