Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

2 de junio de 2026 actualizado por: Centre Leon Berard

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Lyon, Francia, 69008
        • Reclutamiento
        • Institut d'Hématologie et d'Oncologie Pédiatrique
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To determine the feasibility of testing olfactory, gustatory, and salivary function in children aged 7 to 17 years undergoing chemotherapy.
Periodo de tiempo: T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: T0 : first day of the second cycle of chemotherapy; T1 : 1 month after T0

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Director de estudio: Anestis Dougkas, Lyfe institute

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de diciembre de 2024

Finalización primaria (Actual)

13 de diciembre de 2024

Finalización del estudio (Estimado)

1 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de junio de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre tests

Suscribir