Cancer-related Fatigue, Head and Neck Neoplasms
Conditions
Brief summary
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.
Interventions
BEHAVIORALTai Chi Intervention Group
Participants will receive an approximately 12-week Yang-style 16-form Tai Chi program in addition to standardized usual care. The intervention will begin approximately 2 weeks before radiotherapy during the radiotherapy preparation period and will be delivered mainly through in-person group sessions led by a qualified Tai Chi instructor, with safety management provided by rehabilitation and medical staff. Each session will include warm-up, Yang-style 16-form Tai Chi practice, and cool-down. The intervention includes an introductory learning phase, a radiotherapy phase, and a post-radiotherapy consolidation phase. During radiotherapy, the exercise program may be adjusted according to the participant's physical condition and treatment-related symptoms, including changes in movement amplitude, pace, rest intervals, and training duration. Training intensity or duration may be reduced, or sessions may be temporarily suspended, when clinically indicated.
BEHAVIORALUsual Care and Health Education
Participants will receive usual care, health education, and activity recording during the study period.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 0-1. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy | Baseline to within 7 days after the final radiotherapy session |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTXingchen Peng
Outcome results
None listed