A Prospective Randomized Controlled Phase II Trial of Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy
研究概览
简要总结
This prospective, randomized controlled study will evaluate whether a Tai Chi exercise program can help reduce cancer-related fatigue in patients with head and neck cancer undergoing radiotherapy.
A total of 116 participants will be randomly assigned in a 1:1 ratio to either a Tai Chi intervention group or a control group. Participants in the Tai Chi group will receive usual cancer care together with a 12-week Yang-style 16-form Tai Chi program. The exercise program will begin during radiotherapy preparation and will be adjusted according to the participant's treatment phase and physical condition. Participants in the control group will receive usual care, health education, and activity recording.
The primary outcome is the change in cancer-related fatigue from baseline to within 7 days after completion of radiotherapy, measured using the Brief Fatigue Inventory (BFI) global score. The study will also assess fatigue at week 12 and functional exercise capacity using the 6-minute walk test.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary malignant tumor of the head and neck and planned to receive radiotherapy.
- •Age 18 to 80 years.
- •No regular exercise during the previous 3 months, defined as less than 150 minutes per week of moderate-intensity exercise and less than 75 minutes per week of vigorous-intensity exercise.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Able to complete the baseline assessment before the start of radiotherapy.
- •Provides written informed consent and is willing to comply with the supervised exercise program.
排除标准
- •Absolute contraindications to exercise, such as uncontrolled heart failure, severe arrhythmia, acute myocardial infarction, unstable angina, or severe aortic stenosis.
- •Severe musculoskeletal disease, neurological disease, or other physical disease that prevents completion of the prescribed exercise movements.
- •Uncontrolled brain metastases or severe bone metastases associated with a high risk of pathological fracture.
- •Severe cognitive impairment or psychiatric disorder, such as severe depression or schizophrenia, that prevents compliance with study instructions.
- •Pregnancy or breastfeeding.
- •Other conditions that may substantially confound fatigue assessment, including severe anemia (hemoglobin <9.0 g/dL); hypothyroidism with thyroid-stimulating hormone (TSH) >5 mIU/L accompanied by clinical symptoms; hyperthyroidism with TSH <0.3 mIU/L without stable treatment; Insomnia Severity Index (ISI) score ≥15 with symptoms remaining unstable despite routine sleep management; or pain with a Numeric Rating Scale (NRS) score ≥4 that remains uncontrolled despite optimized analgesic management or requires escalation of treatment.
- •Participation in another structured exercise rehabilitation program or interventional study that may substantially affect the study outcomes.
研究组 & 干预措施
Control Group
干预措施: Usual Care and Health Education (Behavioral)
Tai Chi Intervention Group
干预措施: Tai Chi Intervention Group (Behavioral)
结局指标
主要结局
Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy
时间窗: Baseline to within 7 days after the final radiotherapy session
次要结局
- Change From Baseline in Brief Fatigue Inventory Global Score at Week 12(Baseline to Week 12)
- Change From Baseline in 6-Minute Walk Distance at Week 12(Baseline to Week 12)
研究者
Xingchen Peng
Professor
West China Hospital