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

February 24, 2025 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

Recruiting

Conditions

Intervention / Treatment

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, the most robust evidence demonstrated in patients with prostate, breast and colorectal cancers, the effectiveness of exercise interventions in Head and Neck cancer survivors is 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 literatures, 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 focus on the integration of the basic and clinical research. The multidisciplinary research teams include participants of the Department of Hematology and Oncology and Department of Rehabilitation of the New Taipei City Tucheng Hospital. The main purpose of 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 above research materials for subjects including recruiting in 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 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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • 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 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Head and Neck patient after CCRT treatment with HIIT training

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
keep follow the PFS and OS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of participants with phenoage and age
Time Frame: 1 month, after CCRT
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
1 month, after CCRT
% of participants with phenoage and age
Time Frame: 6 month, after CCRT
To evaluate the phenoage acceleration by calculating differencehe of patients with phenoage and age.
6 month, after CCRT
Peak VO2 (ml/min/kg) of participants
Time Frame: baseline
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training
baseline
Peak VO2 (ml/min/kg) of participants
Time Frame: 1 month, after CCRT
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training
1 month, after CCRT
Peak VO2 (ml/min/kg) of participants
Time Frame: 6 month, after CCRT
To record the Peak VO2 (ml/min/kg) of participants and to evulate the effectiveness of exercise training
6 month, after CCRT
Questionnaire of European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43)
Time Frame: baseline
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
baseline
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 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
1 month, after 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 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
6 month, after CCRT

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • 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)

May 3, 2023

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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