Taste Steering in Patients With Cancer Who Are Treated With Chemotherapy: a Multicentre Randomized Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 11
- 主要终点
- Food enjoyment in appetite, hunger and sensory perception
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Taste steering (Behavioral)
No intervention
standard of care
结局指标
主要结局
Food enjoyment in appetite, hunger and sensory perception
时间窗: 6 weeks
Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care. The AHSP uses a 5-point Likert scale (1-5), with higher scores indicating greater appetite, hunger, or sensory changes.
Food enjoyment
时间窗: 6 weeks
Food enjoyment, measured by the subsection of the Appetite, Hunger and Sensory Perception Questionnaire (AHSP) after 6 weeks of taste steering compared with standard care
次要结局
- Health-related quality of life(6 weeks)
- Body weight(6 weeks)
- Taste and smell alterations(6 weeks)
- Risk of malnutrition(6 weeks)
- Food enjoyment and liking(6 weeks)
- Quality of life(6 weeks)
- Dry mouth feeling(6 weeks)
- Taste and smell function(6 weeks)
- Saliva secretion(6 weeks)