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临床试验/NCT05816369
NCT05816369招募中不适用

Taste and Smell Alterations and Oral Nutritional Supplement (ONS) Preferences in Patients With Cancer

University of Bergen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Flavor liking of five different oral nutritional supplement flavors.

研究概览

简要总结

Patients diagnosed with cancer have a particularly high risk of developing malnutrition due to the disease itself and due to symptoms of cancer treatments that can affect food intake such as reduced appetite, nausea, fatigue, and alterations in taste and smell. Nutritional treatment is essential in the prevention and treatment of malnutrition. Oral nutritional supplements (ONS) are often recommended to cancer patients who need to increase their nutritional intake and are unable to meet their nutritional requirements by consumption of normal food alone. However, patient compliance with ONS depends on sensory acceptability of such products. Therefore, the objective of this study is to investigate preferences of sensory characteristics of ONS among cancer patients. Additionally, possible associations between taste and smell alterations and dietary intake, malnutrition risk, and quality of life will be investigated. The results from this study will optimize recommendations of ONS in the clinical setting and encourage new efforts among manufacturers in developing acceptable sensory characteristics of ONS to cancer patients. Findings from this study will contribute to improving nutritional treatment for cancer patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ambulatory patients diagnosed with lung cancer
  • Patients receiving cancer treatment of different types
  • Age 18 years or more
  • Provided signed informed consent
  • Understand written and oral Norwegian

排除标准

  • Severe mental or cognitive disorders
  • Contraindication to consume ONS (dysphagia, inability to swallow oral nutritional supplements)
  • Allergic or intolerant to any of the ingredients in the ONS
  • Terminally ill patients (<3 months to live)
  • A clinically significant disease or condition that could, in the investigator's opinion make the patient unfit for the study

结局指标

主要结局

Flavor liking of five different oral nutritional supplement flavors.

时间窗: 30 minutes

To evaluate patient liking of five different oral nutritional supplement flavors using a taste test and a questionnaire with a 9-point Hedonic scale (possible score from 1 to 9) assessing flavor liking. A higher score indicates better liking.

次要结局

  • Quality of life.(10 minutes)
  • Liking of ONS characteristics with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).(30 minutes)
  • Self-reported taste and smell alterations.(10 minutes)
  • Prevalence of malnutrition risk.(5 minutes)
  • Dietary intake.(3 days)
  • Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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