Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tai Chi Intervention Group
BehavioralParticipants 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
BehavioralParticipants will receive usual care, health education, and activity recording during the study period.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Tai Chi Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy
Time frame
Baseline to within 7 days after the final radiotherapy sessionSecondary outcomes
1
Change From Baseline in Brief Fatigue Inventory Global Score at Week 12
Time frame
Baseline to Week 122
Change From Baseline in 6-Minute Walk Distance at Week 12
Time frame
Baseline to Week 12Other outcomes
1
EORTC QLQ-C30 Scores
Time frame
Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization2
EORTC QLQ-H&N35 Scores
Time frame
Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization3
Hospital Anxiety and Depression Scale Scores
Time frame
Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization4
Distress Thermometer Score
Time frame
Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomizationSponsors and contacts
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Source ClinicalTrials.gov