NCT07809776

Brief 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. 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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Nov 2027

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 2, 2026

Last Update Submit

September 10, 2026

Conditions

Head and Neck NeoplasmsCancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Brief Fatigue Inventory Global Score After Completion of Radiotherapy

    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

    Baseline to Week 12

  • Change From Baseline in 6-Minute Walk Distance at Week 12

    Baseline to Week 12

Other Outcomes (7)

  • EORTC QLQ-C30 Scores

    Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization

  • EORTC QLQ-H&N35 Scores

    Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization

  • Hospital Anxiety and Depression Scale Scores

    Baseline, within 7 days after the final radiotherapy session, and Week 12 after randomization

  • +4 more other outcomes

Study Arms (2)

Tai Chi Intervention Group

EXPERIMENTAL
Behavioral: Tai Chi Intervention Group

Control Group

ACTIVE COMPARATOR
Behavioral: Usual Care and Health Education

Interventions

Usual Care and Health EducationBEHAVIORAL

Participants will receive usual care, health education, and activity recording during the study period.

Control Group
Tai Chi Intervention GroupBEHAVIORAL

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.

Tai Chi Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 15050660RESULT

  • Mendoza 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.

    PMID: 10091805RESULT

  • Mustian 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.

    PMID: 28253393RESULT

  • Jereczek-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.

    PMID: 17398020RESULT

  • Nayak 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.

    PMID: 39572312RESULT

  • Bower 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.

    PMID: 38754041RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Central Study Contacts

Xingchen Peng

CONTACT

18980606753pxx2014@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)