[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655141":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":56,"overallOfficials":11,"centralContacts":65,"locations":71,"responsibleParty":89,"collaborators":11,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":11,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"West China Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy",null,"Baseline to within 7 days after the final radiotherapy session",[14,17],{"measure":15,"description":11,"timeFrame":16},"Change From Baseline in Brief Fatigue Inventory Global Score at Week 12","Baseline to Week 12",{"measure":18,"description":11,"timeFrame":16},"Change From Baseline in 6-Minute Walk Distance at Week 12",[20,23,25,27,29,32,35],{"measure":21,"description":11,"timeFrame":22},"EORTC QLQ-C30 Scores","Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization",{"measure":24,"description":11,"timeFrame":22},"EORTC QLQ-H&N35 Scores",{"measure":26,"description":11,"timeFrame":22},"Hospital Anxiety and Depression Scale Scores",{"measure":28,"description":11,"timeFrame":22},"Distress Thermometer Score",{"measure":30,"description":11,"timeFrame":31},"Radiotherapy Completion Rate","Within 7 days after the final radiotherapy session",{"measure":33,"description":11,"timeFrame":34},"Overall Radiotherapy Treatment Time","From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks",{"measure":36,"description":11,"timeFrame":34},"Radiotherapy Interruption Days",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":42,"maskingDescription":11,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR",[46,51],{"label":47,"type":48,"description":11,"interventionNames":49},"Tai Chi Intervention Group","EXPERIMENTAL",[50],"Behavioral: Tai Chi Intervention Group",{"label":52,"type":53,"description":11,"interventionNames":54},"Control Group","ACTIVE_COMPARATOR",[55],"Behavioral: Usual Care and Health Education",[57,61],{"type":58,"name":47,"description":59,"armGroupLabels":60,"otherNames":11},"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.",[47],{"type":58,"name":62,"description":63,"armGroupLabels":64,"otherNames":11},"Usual Care and Health Education","Participants will receive usual care, health education, and activity recording during the study period.",[52],[66],{"name":67,"role":68,"phone":69,"phoneExt":11,"email":70},"Xingchen Peng","CONTACT","18980606753","pxx2014@163.com",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"West China Hospital, Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":81,"coordinates":82},"Point",[83,84],104.06667,30.66667,{"lat":84,"lon":83},[87],{"name":67,"role":68,"phone":88,"phoneExt":11,"email":70},"+86 18980606753",{"type":90,"investigatorFullName":67,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Professor","100655141","tai-chi-for-cancer-related-fatigue-during-radiotherapy-in-patients-with-head-and-neck-cancer-100655141",false,"NCT07809776","Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Cancer","A Prospective Randomized Controlled Phase II Trial of Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Malignancies","Inclusion Criteria:\n\n* Histologically confirmed primary malignant tumor of the head and neck and planned to receive radiotherapy.\n* Age 18 to 80 years.\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Able to complete the baseline assessment before the start of radiotherapy.\n* Provides written informed consent and is willing to comply with the supervised exercise program.\n\nExclusion Criteria:\n\n* Absolute contraindications to exercise, such as uncontrolled heart failure, severe arrhythmia, acute myocardial infarction, unstable angina, or severe aortic stenosis.\n* Severe musculoskeletal disease, neurological disease, or other physical disease that prevents completion of the prescribed exercise movements.\n* Uncontrolled brain metastases or severe bone metastases associated with a high risk of pathological fracture.\n* Severe cognitive impairment or psychiatric disorder, such as severe depression or schizophrenia, that prevents compliance with study instructions.\n* Pregnancy or breastfeeding.\n* Other conditions that may substantially confound fatigue assessment, including severe anemia (hemoglobin \\\u003C9.0 g\u002FdL); hypothyroidism with thyroid-stimulating hormone (TSH) \\>5 mIU\u002FL accompanied by clinical symptoms; hyperthyroidism with TSH \\\u003C0.3 mIU\u002FL 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.\n* Participation in another structured exercise rehabilitation program or interventional study that may substantially affect the study outcomes.","ALL","18 Years","80 Years",{"count":103,"type":104},116,"ESTIMATED","INTERVENTIONAL",[107],"NA","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.\n\nA 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.\n\nThe 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.",[110,111],"Head and Neck Neoplasms","Cancer-related Fatigue","2026-09-10",{"date":114,"type":115},"2026-09-15","ACTUAL",{"date":112,"type":115},{"date":118,"type":104},"2027-11",{"name":5,"class":6},1]