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

NCT07632560 | Recruiting

• 1 other identifier: ET23-394
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Oncology; Pediatric Hematologic Malignancies

Keywords

taste alteration; sensory alteration; chemotherapy; pediatrics

Outcome Measures

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

  T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0

Secondary 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

  T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0

Study Arms (1)

Experimental arm

EXPERIMENTAL

The 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.

Diagnostic Test: tests

Interventions

tests DIAGNOSTIC_TEST

The 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.

Experimental arm

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• Institut Lyfe: collaborator

Study Sites (1)

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anestis Dougkas

  Lyfe institute

  STUDY DIRECTOR

Central Study Contacts

Samia Saraya

CONTACT

+33767889375; ssaraya-jean@institutlyfe.com

Séverine Bouttefroy

CONTACT

severine.bouttefroy@ihope.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: June 8, 2026
• Study Start: December 13, 2024
• Primary Completion: December 13, 2024
• Study Completion: June 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)