The TASTY-steering Study

Официальное название

Taste Steering in Patients With Cancer Who Are Treated With Chemotherapy: a Multicentre Randomized Intervention Trial

Обзор

This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands. A parallel cluster design per hospital was selected to prevent contact between participants in the same hospital who are randomised into different study arms. Such contact may result in bias as it may allow for patients in the control arm to be informed about elements of taste steering. To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital during regular visits. Patients in both study arms are contacted by their dietitian every 3 weeks. Some hospitals have implemented elements of taste steering. However, these elements are focused on patients who are admitted to the hospital, and therefore only interfere to a limited extent with the present study that is directed at patients managing their taste alterations at home. Experience with the Smaakpupil tool indicates that the algorithm reaches saturation after 3-4 weeks. Therefore, an intervention period of 6 weeks has been selected.

Вмешательства

• Поведенческое Taste steering
  To examine the effect of at-home taste steering versus standard care on food enjoyment, the obtained results and outcomes will be measured 1) at baseline before chemotherapy is started, 2) at week 0 when taste or smell alterations occur, and 3) after 6 weeks. The taste steering will take place at home. The control group will receive usual care. Questionnaires will be filled in online at home, while taste and smell tests and saliva collection will be conducted either at home or in the hospital du

Первичные конечные точки

• Food enjoyment in appetite, hunger and sensory perception [Срок оценки: 6 weeks]

Вторичные конечные точки (8)

• Food enjoyment and liking [Срок оценки: 6 weeks]
• Health-related quality of life [Срок оценки: 6 weeks]
• Taste and smell alterations [Срок оценки: 6 weeks]
• Risk of malnutrition [Срок оценки: 6 weeks]
• Dry mouth feeling [Срок оценки: 6 weeks]
• Taste and smell function [Срок оценки: 6 weeks]
• Saliva secretion [Срок оценки: 6 weeks]
• Body weight [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Age ≥18 and ≤70 years
• Indication to start chemotherapy for:

• Metastatic triple negative breast cancer
• Metastatic testicular cancer
• Stage II-IV diffuse large B cell lymphoma
• Chemotherapy scheduled to start in the next 6 weeks
• Consuming solid foods and drinks is possible
• ≤50% of recommended daily intake in kcal consists of oral nutritional supplements
• Oral mucositis grade ≤2 (Common Terminology Criteria for Adverse Events, version 5.0)
• Ability to comply with all protocol-required actions
• Written informed consent
• For the intervention phase only: subjective change in taste since start of chemotherapy

Критерии исключения

• Pregnancy
• Currently experiencing taste or smell problems
• Previous or current radiotherapy of head and neck region
• Enteral feeding through tube or parenteral feeding
• Participation in another clinical trial aimed at preventing or treating taste and/or smell alterations
• Chronic (>1 month) high dose corticosteroids (>10 mg prednisone/day or equivalent).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 11 центров

• Amsterdam UMC — Amsterdam
• Rijnstate Ziekenhuis — Arnhem
• Van Weel-Bethesda Ziekenhuis — Dirksland
• Ziekenhuisvoorzieningen Gelderse Vallei — Ede
• University Medical Center Groningen — Groningen
• Martini Ziekenhuis — Groningen
• Radboud University Medical Center — Nijmegen
• Ikazia Ziekenhuis — Rotterdam
• … и ещё 3 центра

Идентификаторы

NCT: NCT07258563 · 20862

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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