Head and Neck NeoplasmsNCT07809776
Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Cancer
A study testing Tai Chi Intervention Group in people with Head and Neck Neoplasms and Cancer-related Fatigue, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Neoplasms, Cancer-related Fatigue
- What is being tested?
- Tai Chi Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, +86 18980606753, pxx2014@163.com
About this study
Official title: A Prospective Randomized Controlled Phase II Trial of Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Malignancies
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.
- Conditions
- Head and Neck Neoplasms, Cancer-related Fatigue
- Being tested
- Tai Chi Intervention Group, Usual Care and Health Education
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi Intervention GroupBehavioural
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 EducationBehavioural
Participants will receive usual care, health education, and activity recording during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Intervention Group | Experimental | Not described Receives: Behavioral: Tai Chi Intervention Group |
| Control Group | Active comparator | Not described Receives: Behavioral: Usual Care and Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy
Measured: Baseline to within 7 days after the final radiotherapy session
Secondary outcomes (2)
Change From Baseline in Brief Fatigue Inventory Global Score at Week 12
Measured: Baseline to Week 12
Change From Baseline in 6-Minute Walk Distance at Week 12
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Sep 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809776
- Sponsor's protocol ID
- 2026-1928
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang XS, Hao XS, Wang Y, Guo H, Jiang YQ, Mendoza TR, Cleeland CS. Validation study of the Chinese version of the Brief Fatigue Inventory (BFI-C). J Pain Symptom Manage. 2004 Apr;27(4):322-32. doi: 10.1016/j.jpainsymman.2003.09.008.
PubMed 15050660Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
PubMed 10091805Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA Oncol. 2017 Jul 1;3(7):961-968. doi: 10.1001/jamaoncol.2016.6914.
PubMed 28253393Jereczek-Fossa BA, Santoro L, Alterio D, Franchi B, Fiore MR, Fossati P, Kowalczyk A, Canino P, Ansarin M, Orecchia R. Fatigue during head-and-neck radiotherapy: prospective study on 117 consecutive patients. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):403-15. doi: 10.1016/j.ijrobp.2007.01.024. Epub 2007 Mar 29.
PubMed 17398020Nayak SG, Sharan K, Nagaraja R, George A. Effectiveness of Exercise-Based Interventions on Fatigue among Head and Neck Cancer Patients on Radiotherapy: Systematic Review with Meta-Analysis. Semin Oncol Nurs. 2025 Feb;41(1):151755. doi: 10.1016/j.soncn.2024.151755. Epub 2024 Nov 20.
PubMed 39572312Bower JE, Lacchetti C, Alici Y, Barton DL, Bruner D, Canin BE, Escalante CP, Ganz PA, Garland SN, Gupta S, Jim H, Ligibel JA, Loh KP, Peppone L, Tripathy D, Yennu S, Zick S, Mustian K. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update. J Clin Oncol. 2024 Jul 10;42(20):2456-2487. doi: 10.1200/JCO.24.00541. Epub 2024 May 16.
PubMed 38754041
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Phase II Trial of Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Malignancies
- ClinicalTrials.gov ID
- NCT07809776
- Acronym / sponsor ID
- 2026-1928
- Conditions
- Head and Neck Neoplasms, Cancer-related Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Intervention Group | Experimental | Behavioral: Tai Chi Intervention Group |
| Control Group | Active comparator | Behavioral: Usual Care and Health Education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi Intervention GroupParticipants 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. | Behavioural | Tai Chi Intervention Group |
| Usual Care and Health EducationParticipants will receive usual care, health education, and activity recording during the study period. | Behavioural | Control Group |
Primary outcome
Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy
Time frame: Baseline to within 7 days after the final radiotherapy session
2 secondary outcomes
Change From Baseline in Brief Fatigue Inventory Global Score at Week 12
Time frame: Baseline to Week 12
Change From Baseline in 6-Minute Walk Distance at Week 12
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 15050660Wang XS, Hao XS, Wang Y, Guo H, Jiang YQ, Mendoza TR, Cleeland CS. Validation study of the Chinese version of the Brief Fatigue Inventory (BFI-C). J Pain Symptom Manage. 2004 Apr;27(4):322-32. doi: 10.1016/j.jpainsymman.2003.09.008.
- Results publication: PubMed 10091805Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
- Results publication: PubMed 28253393Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA Oncol. 2017 Jul 1;3(7):961-968. doi: 10.1001/jamaoncol.2016.6914.
- Results publication: PubMed 17398020Jereczek-Fossa BA, Santoro L, Alterio D, Franchi B, Fiore MR, Fossati P, Kowalczyk A, Canino P, Ansarin M, Orecchia R. Fatigue during head-and-neck radiotherapy: prospective study on 117 consecutive patients. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):403-15. doi: 10.1016/j.ijrobp.2007.01.024. Epub 2007 Mar 29.
- Results publication: PubMed 39572312Nayak SG, Sharan K, Nagaraja R, George A. Effectiveness of Exercise-Based Interventions on Fatigue among Head and Neck Cancer Patients on Radiotherapy: Systematic Review with Meta-Analysis. Semin Oncol Nurs. 2025 Feb;41(1):151755. doi: 10.1016/j.soncn.2024.151755. Epub 2024 Nov 20.
- Results publication: PubMed 38754041Bower JE, Lacchetti C, Alici Y, Barton DL, Bruner D, Canin BE, Escalante CP, Ganz PA, Garland SN, Gupta S, Jim H, Ligibel JA, Loh KP, Peppone L, Tripathy D, Yennu S, Zick S, Mustian K. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update. J Clin Oncol. 2024 Jul 10;42(20):2456-2487. doi: 10.1200/JCO.24.00541. Epub 2024 May 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Intervention Group in people with Head and Neck Neoplasms and Cancer-related Fatigue, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy (time frame: Baseline to within 7 days after the final radiotherapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07809776, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.