A prospective randomized controlled phase II trial of tai chi for Cancer-Related fatigue during radiotherapy in patients with head and neck malignancies

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.