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

2026年6月2日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Lyon、フランス、69008
        • 募集
        • Institut d'Hématologie et d'Oncologie Pédiatrique
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
To determine the feasibility of testing olfactory, gustatory, and salivary function in children aged 7 to 17 years undergoing chemotherapy.
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • スタディディレクター:Anestis Dougkas、Lyfe institute

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年12月13日

一次修了 (実際)

2024年12月13日

研究の完了 (推定)

2026年6月1日

試験登録日

最初に提出

2026年3月10日

QC基準を満たした最初の提出物

2026年6月2日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月8日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年3月1日

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