AgingNCT06851988
Can Exercise Ameliorate Immunosenescence and Thereby Reduce Relapse in Head and Neck Cancer Patients
A study testing HIIT & Record of physical activities at home. and HIIT only in people with Aging and High-intensity Interval Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will encourage and promise and add further support to the concept that exercise prescription is worth implementation as part of care… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Aging, High-intensity Interval Training, Head and Neck Cancers - Tonsils
- What is being tested?
- HIIT & Record of physical activities at home. and HIIT only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2023to 30 Oct 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20
- Pathology:Squamous cell carcinoma
- Need CCRT treatment
- ECOG PS<2
- Agree with blood drawing, excise training, questionnaire
Who cannot join
- ECOG PS≥2
- Unable to tolerate basic exercise, or CCRT treatment
- Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
- Any medical condition that unsuitable for exercise
- Disagree to trial procedures: exercise, blood draws, questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kuo contact
Taiwan1 site, 1 recruiting
- Recruiting
TuCheng Hospital
New Taipei City, 23652
Chia-Hsun Hsieh, PhD, 0975366137, wisdom5000@cgmh.org.tw
About this study
Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will encourage and promise and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.
Read the detailed description
Cancer patients have theoretically returned to a disease-free state after receiving curative anticancer therapy, but even after receiving adjuvant concurrent chemoradiotherapy, it does not ideally prevent all cancer recurrences. For that, several guidelines recommend that cancer survivors participate in regular exercise. Exercise has been thought to be associated with improved outcomes and mortality in healthy individuals as well as in certain cancer populations. However, while the most robust evidence has been demonstrated in patients with prostate, breast and colorectal cancers, the effectiveness of exercise interventions in Head and Neck cancer survivors remains inadequately understood.
Aging of the immune system (so-called immunosenescence) has long been known to increase the risk of infection, cancer, chronic inflammatory diseases and age-related multi-morbidity in humans. In the literature, patients with oral cavity cancer are also believed to have the phenomenon of immune aging (immunosenescence). One of the mechanisms that maintain cellular homeostasis and prevent immunosenescence-related damage is autophagy, a cell-survival mechanism, and it has been proposed as one of the most powerful antiaging therapies. Regular exercise can reestablish autophagy, probably through AMP-activated protein kinase activation, and help in reducing the age-related senescence diseases. At present, many research teams in cancer centers are trying to design large-scale prospective trials to answer whether the intervention of exercise can avoid cancer occurrence, health promotion in survivors, and prevention of recurrence.
This project focuses on the integration of the basic and clinical research. The multidisciplinary research team consists of members from the Department of Hematology and Oncology and Department of Rehabilitation of the New Taipei City Tucheng Hospital and Linkou Chang Gung Memorial Hospital. The main purpose of this three-year project is to investigate whether high-intensity interval training (HIIT) along with resistance exercise intervention, which could reduce the recurrence rate by ameliorating immunosenescence on patients with head and neck cancer. The main tasks order by year of this project are as the following: (1) investigating the differences of immunosenescence indicators in blood with before and after conducting eight weeks of HIIT along with resistance exercise training for patients with head and neck cancer (1st year plan); (2) recruiting new subjects, gathering the physical activity at home and the cancer recurrence rate for first-year subjects, investigating the differences of immunosenescence indicators and immune indicators in the peripheral blood, and examining the clinical effectiveness of exercise training (2nd year plan); (3) Tracking the clinical data and research materials for subjects recruited during the first and second years (3rd year plan). Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will provide promising evidence and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.
- Being tested
- HIIT & Record of physical activities at home., HIIT only
- Keywords
- Exercise, Immunosenescence, Recurrence-free survival, Head and Neck Cancer
- Medical subject headings
- Motor Activity, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT & Record of physical activities at home.Other
After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times. And record of physical activities at home. According to the record set goal to acheive.
HIIT onlyOther
After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck patient after CCRT treatment with HIIT training-Experimental group | Experimental | After CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times.
keep follow the PFS and OS Receives: Other: HIIT & Record of physical activities at home.; Other: HIIT only |
| Head and Neck patient after CCRT treatment-Experimental group | No intervention | keep follow the PFS and OS |
| Head and Neck patient after CCRT treatment with HIIT training-Validation group | Experimental | After CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times.
keep follow the PFS and OS Receives: Other: HIIT & Record of physical activities at home.; Other: HIIT only |
| Head and Neck patient after CCRT treatment-Validation group | No intervention | keep follow the PFS and OS |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of participants with phenoage and age
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
Measured: baseline before CCRT
percent of participants with phenoage and age
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
Measured: 1 months after the completion of CCRT
percent of participants with phenoage and age
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
Measured: 6 months after the completion of CCRT
percent of participants with phenoage and age
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
Measured: 9 months after the completion of CCRT
Peak VO2 (ml/min/kg) of participants
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training
Measured: baseline before CCRT
Peak VO2 (ml/min/kg) of participants
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training.The higher scores mean a better outcome.
Measured: 1 months after the completion of CCRT
Peak VO2 (ml/min/kg) of participants
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training.The higher scores mean a better outcome.
Measured: 6 months after the completion of CCRT
Peak VO2 (ml/min/kg) of participants
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training. The higher scores mean a better outcome.
Measured: 9 months after the completion of CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Measured: baseline before CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Measured: 1 month after the completion of CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Measured: 6 month after the completion of CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Measured: 9 month after the completion of CCRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start3 May 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital
- Investigators
- Chia-Hsun Hsieh, Study chair, New Tipei City Tucheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851988
- Sponsor's protocol ID
- 202201332B0
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise Ameliorate Immunosenescence and Thereby Reduce Relapse in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT06851988
- Acronym / sponsor ID
- 202201332B0
- Keywords
- Exercise, Immunosenescence, Recurrence-free survival, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will encourage and promise and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.
Detailed description
Cancer patients have theoretically returned to a disease-free state after receiving curative anticancer therapy, but even after receiving adjuvant concurrent chemoradiotherapy, it does not ideally prevent all cancer recurrences. For that, several guidelines recommend that cancer survivors participate in regular exercise. Exercise has been thought to be associated with improved outcomes and mortality in healthy individuals as well as in certain cancer populations. However, while the most robust evidence has been demonstrated in patients with prostate, breast and colorectal cancers, the effectiveness of exercise interventions in Head and Neck cancer survivors remains inadequately understood.
Aging of the immune system (so-called immunosenescence) has long been known to increase the risk of infection, cancer, chronic inflammatory diseases and age-related multi-morbidity in humans. In the literature, patients with oral cavity cancer are also believed to have the phenomenon of immune aging (immunosenescence). One of the mechanisms that maintain cellular homeostasis and prevent immunosenescence-related damage is autophagy, a cell-survival mechanism, and it has been proposed as one of the most powerful antiaging therapies. Regular exercise can reestablish autophagy, probably through AMP-activated protein kinase activation, and help in reducing the age-related senescence diseases. At present, many research teams in cancer centers are trying to design large-scale prospective trials to answer whether the intervention of exercise can avoid cancer occurrence, health promotion in survivors, and prevention of recurrence.
This project focuses on the integration of the basic and clinical research. The multidisciplinary research team consists of members from the Department of Hematology and Oncology and Department of Rehabilitation of the New Taipei City Tucheng Hospital and Linkou Chang Gung Memorial Hospital. The main purpose of this three-year project is to investigate whether high-intensity interval training (HIIT) along with resistance exercise intervention, which could reduce the recurrence rate by ameliorating immunosenescence on patients with head and neck cancer. The main tasks order by year of this project are as the following: (1) investigating the differences of immunosenescence indicators in blood with before and after conducting eight weeks of HIIT along with resistance exercise training for patients with head and neck cancer (1st year plan); (2) recruiting new subjects, gathering the physical activity at home and the cancer recurrence rate for first-year subjects, investigating the differences of immunosenescence indicators and immune indicators in the peripheral blood, and examining the clinical effectiveness of exercise training (2nd year plan); (3) Tracking the clinical data and research materials for subjects recruited during the first and second years (3rd year plan). Through the implementation of this three-year project, investigators expect to find a safe and effective exercise prescription for patients with oral cancer after surgery. The findings will provide promising evidence and add further support to the concept that exercise prescription is worth implementation as part of care for the patients with head and neck cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Head and Neck patient after CCRT treatment with HIIT training-Experimental group | Experimental | Other: HIIT & Record of physical activities at home., Other: HIIT onlyAfter CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times. keep follow the PFS and OS |
| Head and Neck patient after CCRT treatment-Experimental group | No intervention | –keep follow the PFS and OS |
| Head and Neck patient after CCRT treatment with HIIT training-Validation group | Experimental | Other: HIIT & Record of physical activities at home., Other: HIIT onlyAfter CCRT treatment 4-5 week arrange HIIT training for patient. Two to three times a week ,total 24-36 times. keep follow the PFS and OS |
| Head and Neck patient after CCRT treatment-Validation group | No intervention | –keep follow the PFS and OS |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥20
- Pathology:Squamous cell carcinoma
- Need CCRT treatment
- ECOG PS<2
- Agree with blood drawing, excise training, questionnaire
Key exclusion criteria (5 listed)
- ECOG PS≥2
- Unable to tolerate basic exercise, or CCRT treatment
- Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
- Any medical condition that unsuitable for exercise
- Disagree to trial procedures: exercise, blood draws, questionnaire
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 |
|---|---|---|
| HIIT & Record of physical activities at home.After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times. And record of physical activities at home. According to the record set goal to acheive. | Other | Head and Neck patient after CCRT treatment with HIIT training-Experimental group, Head and Neck patient after CCRT treatment with HIIT training-Validation group |
| HIIT onlyAfter CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times. | Other | Head and Neck patient after CCRT treatment with HIIT training-Experimental group, Head and Neck patient after CCRT treatment with HIIT training-Validation group |
Primary outcome
percent of participants with phenoage and age
Time frame: baseline before CCRT
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
percent of participants with phenoage and age
Time frame: 1 months after the completion of CCRT
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
percent of participants with phenoage and age
Time frame: 6 months after the completion of CCRT
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
percent of participants with phenoage and age
Time frame: 9 months after the completion of CCRT
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
Peak VO2 (ml/min/kg) of participants
Time frame: baseline before CCRT
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training
Peak VO2 (ml/min/kg) of participants
Time frame: 1 months after the completion of CCRT
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training.The higher scores mean a better outcome.
Peak VO2 (ml/min/kg) of participants
Time frame: 6 months after the completion of CCRT
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training.The higher scores mean a better outcome.
Peak VO2 (ml/min/kg) of participants
Time frame: 9 months after the completion of CCRT
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training. The higher scores mean a better outcome.
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Time frame: baseline before CCRT
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Time frame: 1 month after the completion of CCRT
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Time frame: 6 month after the completion of CCRT
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Time frame: 9 month after the completion of CCRT
To assese the quality of life at the Head and Neck participants and evulate the effectiveness of exercise training.The minimum value is 43 and the maximum value is 172. The higher scores mean a worse outcome.
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 24 Sep 2026.
- 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.
Kuo contact
Chia-Hsun Hsieh study chair
New Tipei City Tucheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT & Record of physical activities at home. and HIIT only in people with Aging and High-intensity Interval Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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 24 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 Taiwan. 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 Wan-Chin Kuo (03-3196200 ext. 3708, troublefup6@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of participants with phenoage and age (time frame: baseline before CCRT). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.