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NCT Number: NCT06851988

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

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.

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Key information

Conditions

Aging Behavior Head and Neck Cancers - Tonsils Head and Neck Neoplasms High-Intensity Interval Training Motor Activity Neoplasms Neoplasms by Site

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TuCheng Hospital

New Taipei City, 23652, Taiwan

Location status: Recruiting

Location contact

Chia-Hsun Hsieh, PhD

CONTACT

[email protected]

0975366137

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥20
  • Pathology:Squamous cell carcinoma
  • Need CCRT treatment
  • ECOG PS<2
  • Agree with blood drawing, excise training, questionnaire

Exclusion criteria

  • 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

Treatment and study plan

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 only

Other

After CCRT treatment 4-5 week arrange HIIT excise for patient two to three times a week 24-36 times.

Primary outcomes

  1. % 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.

  2. % 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.

  3. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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

Study contacts

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

Kuo

CONTACT

Wan-Chin Kuo

CONTACT

[email protected]

03-3196200 ext. 3708

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

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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