Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Cancer

• Tai Chi Intervention Group (Behavioral): 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.
• Usual Care and Health Education (Behavioral): Participants will receive usual care, health education, and activity recording during the study period.

Primary outcomes

• Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy [Baseline to within 7 days after the final radiotherapy session]

Secondary outcomes

• 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]

Other outcomes

• EORTC QLQ-C30 Scores [Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization]
• EORTC QLQ-H&N35 Scores [Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization]
• Hospital Anxiety and Depression Scale Scores [Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization]
• Distress Thermometer Score [Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization]
• Radiotherapy Completion Rate [Within 7 days after the final radiotherapy session]
• Overall Radiotherapy Treatment Time [From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks]
• Radiotherapy Interruption Days [From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks]

Sex: All, ages: 18 Years to 80 Years

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.

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