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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Oncology; Pediatric Hematologic Malignancies
• Intervention / Treatment: Diagnostic test: tests

Detailed Description

Today, the chances of survival among children and adolescents who have been diagnosed with cancer are 80%, particularly due to early diagnosis and access to appropriate care. Although multimodal care strategies have improved the survival rate in pediatric patients, highly toxic treatments cause various short- and long-term side effects such as nausea, vomiting, loss of appetite, and alterations in taste perception. These side effects affect the comfort and quality of life of patients and expose them to a high risk of malnutrition. Sensory alterations related to smell, taste and texture reduce appetite and pleasure in eating, thus reducing food intake. More than 45% of children and adolescents treated for cancer suffer from malnutrition, which impacts their immune function, their response to treatments, their quality of life and even the costs of care. The consequences of sensory alterations on behaviors, preferences and eating habits are still little studied in children and adolescents treated for cancer. Similarly, olfactory and somesthetic capacities are very little explored in these patients. Only few studies are available in this area in pediatrics, and no studies take into account texture perception, which is essential for food acceptance.

This study is a feasibility study aimed at exploring the tools for measuring sensory alterations. It aims to evaluate taste and olfactory capacities, as well as food preferences in terms of textures among children. The study is a single-arm intervention. The study will include 30 patients between 7 and 17 years old, newly diagnosed with oncological or hematological malignancies, treated at IHOPE (Institute of Hematology and Pediatric Oncology) in Lyon, until today 3 patients have been included. The protocol had to undergo a second session in the Ethics County for changes to the recruitment process on May 7, 2025, with the aim of having more inclusions of participants. The change consists of doing the tests before the second chemotherapy cycle instead of the first cycle since patients have a lot of procedures to do in hospital management and they did not agree to participate in the study. The measures that are taken are, olfactory and gustatory capacities, measurement of salivary quantity and quality, preference and acceptance of textures. The state of oral health, dietary habits and food consumption with questionnaires are also assessed. 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samia Saraya; Phone Number: +33767889375; Email: ssaraya-jean@institutlyfe.com
• Study Contact Backup: Name: Séverine Bouttefroy; Email: severine.bouttefroy@ihope.fr

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Institut d'Hématologie et d'Oncologie Pédiatrique
    • Contact: Séverine Bouttefroy; Phone Number: +33469166589; Email: severine.bouttefroy@ihope.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: Institut Lyfe
• Investigators: Study Director: Anestis Dougkas, Lyfe institute

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; chemotherapy; sensory alteration; taste alteration
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Taste Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysgeusia
• Other Study ID Numbers: ET23-394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No