West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT07809776
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will receive usual care, health education, and activity recording during the study period.
Time frame: Baseline to within 7 days after the final radiotherapy session
Time frame: Baseline to Week 12
Time frame: Baseline to Week 12
Time frame: Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization
Time frame: Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization
Time frame: Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization
Time frame: Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization
Time frame: Within 7 days after the final radiotherapy session
Time frame: From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks
Time frame: From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks
Contact information is provided by the study sponsor or research team.
West China Hospital
Other
A Prospective Randomized Controlled Phase II Trial of Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Malignancies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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