跳至主要内容
临床试验/NCT05329688
NCT05329688尚未招募不适用

The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy

Taipei Medical University WanFang Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
2
主要终点
BMI

研究概览

简要总结

Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

详细描述

Weight loss is common among cancer patients, and can be attributed to many causes, including mucositis, inability to ingest or absorb adequate calories because of a problem with the alimentary tract, loss of appetite, and metabolic aberrations. Unintentional weight loss may be associated with decreased quality of life (QOL) and a poorer prognosis. Furthermore, for patients who are already in a catabolic state, the increased metabolic demands associated with anticancer treatment (particularly surgery) further worsen the problem. The novel nutrition program might improve the nutrition status and QOL in cancer patients receiving radiotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

single blind (Participant)

入排标准

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

入选标准

  • Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer.
  • Patients need nutrition support treatment
  • Informed consent

排除标准

  • Critical patients or life expectancy < 12 weeks
  • Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
  • Unconscious or psychiatric patients
  • Patients with communication problems

结局指标

主要结局

BMI

时间窗: Week 0, 12

Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.

Quality of Life (QOL)

时间窗: Week 0, 12

The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.

albumin

时间窗: Week 0, 12

level of serum albumin

risk of malnutrition

时间窗: Week 0, 12

Nutrition Risk Screening 2002 is used to assess the risk of malnutrition.

次要结局

  • physical function status(Week 0, 12)
  • Knowledge-Attitude-Practice(Week 0, 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验