Can Exercise Ameliorate Immunosenescence and Thereby Reduce Relapse in Head and Neck Cancer Patients

September 21, 2026 updated by: Jason Chia-Hsun Hsieh, Chang Gung Memorial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Kuo

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 23652
        • Recruiting
        • TuCheng Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥20
  2. Pathology:Squamous cell carcinoma
  3. Need CCRT treatment
  4. ECOG PS<2
  5. Agree with blood drawing, excise training, questionnaire

Exclusion Criteria:

  1. ECOG PS≥2
  2. Unable to tolerate basic exercise, or CCRT treatment
  3. Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
  4. Any medical condition that unsuitable for exercise
  5. Disagree to trial procedures: exercise, blood draws, questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Head and Neck patient after CCRT treatment with HIIT training-Experimental group

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
Other: 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: HIIT only

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.
No Intervention: Head and Neck patient after CCRT treatment-Experimental group

keep follow the PFS and OS
Experimental: Head and Neck patient after CCRT treatment with HIIT training-Validation group

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
Other: 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: HIIT only

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.
No Intervention: Head and Neck patient after CCRT treatment-Validation group

keep follow the PFS and OS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline before CCRT
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.
1 months after the completion of CCRT
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.
6 months after the completion of CCRT
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.
9 months after the completion of CCRT
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
baseline before CCRT
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.
1 months after the completion of CCRT
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.
6 months after the completion of CCRT
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.
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)
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.
baseline before CCRT
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.
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)
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.
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)
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.
9 month after the completion of CCRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chia-Hsun Hsieh, New Tipei City Tucheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202201332B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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