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NCT Number: NCT07809776

Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Cancer

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tai Chi Intervention Group

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.

Usual Care and Health Education

Behavioral

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

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 session

Secondary outcomes

  1. Change From Baseline in Brief Fatigue Inventory Global Score at Week 12

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

Other outcomes

  1. EORTC QLQ-C30 Scores

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

  2. EORTC QLQ-H&N35 Scores

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

  3. Hospital Anxiety and Depression Scale Scores

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

  4. Distress Thermometer Score

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

  5. Radiotherapy Completion Rate

    Time frame: Within 7 days after the final radiotherapy session

  6. Overall Radiotherapy Treatment Time

    Time frame: From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks

  7. Radiotherapy Interruption Days

    Time frame: From the first radiotherapy session through the final radiotherapy session, approximately 6-6.5 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Xingchen Peng

CONTACT

[email protected]

18980606753

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

A Prospective Randomized Controlled Phase II Trial of Tai Chi for Cancer-Related Fatigue During Radiotherapy in Patients With Head and Neck Malignancies

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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