NCT05594069已完成不适用
Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients: a Randomized Controlled Trial
Peking University1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2022年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Critical weight loss
研究概览
简要总结
To evaluate the intervention effect of triple pre-rehabilitation on head and neck cancer patients with radiotherapy, and process evaluation to further optimize the intervention program.
The pre-rehabilitation intervention was develped previously based on the process of evidence-based-nursing, including interventions of nurtrtion, exercise, and psychology.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ age < 75 years old
- •The pathological diagnosis of HNC included nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, salivary gland cancer;
- •Plan to receive radiotherapy
- •Basic communication skills
- •Volunteer to participate in this study.
排除标准
- •Combined with other malignant tumors
- •Distant metastasis
- •Inability to measure body composition, such as metal in the body or inability to stand alone
- •With contraindications to exercise (such as cardiovascular and cerebrovascular diseases, respiratory diseases, etc)
- •Complicated with severe liver and kidney function damage
- •Previous diagnosis of other cancers
- •pregnant or lactation women.
结局指标
主要结局
Critical weight loss
时间窗: About 6 weeks
Weight loss over 5% during radiotherapy
次要结局
- Body composition measured by Bioelectrical Impedance Analysis (BIA)(About 6 weeks)
- Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0(About 6 weeks)
- Patients in the intervention group were interviewed about the compliance of the study(About 6 weeks)
- Intake assessed by a simple diet self-assessment tool (SDSAT)(About 6 weeks)
- Number of participants with intervention-related adverse events(About 6 weeks)
- Physical performance(About 6 weeks)
- Quality of life of patients assessed by QLQ-C30(About 6 weeks)
- Patients in the intervention group were interviewed about the experience of the study(About 6 weeks)
- Psychological status assessed by hospital anxiety and depression scale (HADS)(About 6 weeks)
研究者
luqian@bjmu.edu.cn
professor
Peking University
研究点 (1)
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