Taste and Smell Training in Patients With Cancer Who Are Treated With Tyrosine Kinase Inhibitors: a Multicentre Randomized Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 11
- 主要终点
- Taste function
研究概览
简要总结
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 and smell training.
To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention 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.
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
- •Intention of being treated with tyrosine kinase inhibitors for next 12 weeks.
- •Experiencing taste alterations after starting treatment with tyrosine kinase inhibitors
- •Consuming solid foods and drinks is possible
- •≤50% of recommended daily intake in kcal consisting 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
排除标准
- •Pregnancy
- •History of taste, smell, or saliva production dysfunction before treatment with tyrosine kinase inhibitors
- •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
No intervention
Standard of care
Taste and smell training
To examine the effect of at-home taste and smell training versus standard care on taste function and other outcome parameters, measurements will take place at baseline (before the training starts), and after 12 weeks. The intervention will take place at home.
干预措施: Taste and smell training (Behavioral)
结局指标
主要结局
Taste function
时间窗: 12 weeks
Taste function measured with taste strips at baseline and after week 12 weeks of taste and smell training compared with standard care
次要结局
- Food enjoyment in appetite, hunger and sensory perception(12 weeks)
- Health-related quality of life(12 weeks)
- Taste and smell alterations(12 weeks)
- Risk of malnutrition(12 weeks)
- Dry mouth feeling(12 weeks)
- Saliva secretion(12 weeks)
- Smell function(12 weeks)
- Body weight(12 weeks)