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NCT Number: NCT06666881

Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients

This project adopts a prospective study design. It is scheduled to enroll 60 participants diagnosed with Head and Neck cancer in this hospital, of which 30 are in the experimental group and 30 are in the control group. The purpose of this research is to analyze the skeletal muscle mass changes on images in Head and Neck cancer patients after exercise training and the association with systemic inflammatory markers. Investigators would like to know whether these images and biomarkers predict the prognosis of Head and Neck cancer. Subjects enrolled in the trial will receive 36 times of exercise training after concurrent chemoradiotherapy. Before and after the completion of exercise training, investigators will arrange (1) dual energy X-ray absorptiometry (DXA) to measure the whole-body skeletal muscle mass and appendicular skeletal muscle mass and (2) blood tests for markers of systemic inflammation. In addition to DXA, computed tomography (CT) is another image modality for skeletal muscle mass evaluation. Positron emission tomography - CT or whole-body CT for cancer staging are considered as baseline studies. The routine follow-up CT images are used to analyze the changes after exercise training. If magnetic resonance imaging is also performed during the follow-up period, images will also be collected and assessed as an alternative.If the experimental group can maintain or even improve skeletal muscle mass and can be reflected in blood tests and prognosis, the result may be able to apply on cancer treatment and disease followup.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Taipei City TuCheng Hospital

New Taipei City, Taiwan

Location status: Recruiting

Location contact

ShaoChung Wang, PhD

CONTACT

[email protected]

0978835190

About this study

This project adopts a prospective study design. It is scheduled to enroll 60 patients diagnosed with Head and Neck cancer in this hospital, of which 30 are in the experimental group and 30 are in the control group. The purpose of this research is to analyze the skeletal muscle mass changes on images in Head and Neck cancer participants after exercise training and the association with systemic inflammatory markers. Investigators would like to know whether these images and biomarkers predict the prognosis of head and neck cancer. Subjects enrolled in the trial will receive 36 times of exercise training after concurrent chemoradiotherapy. Before and after the completion of exercise training, investigators will arrange (1) dual energy X-ray absorptiometry (DXA) to measure the whole-body skeletal muscle mass and appendicular skeletal muscle mass and (2) blood tests for markers of systemic inflammation. In addition to DXA, computed tomography (CT) is another image modality for skeletal muscle mass evaluation. Positron emission tomography - CT or whole-body CT for cancer staging are considered as baseline studies. The routine follow-up CT images are used to analyze the changes after exercise training. If magnetic resonance imaging is also performed during the follow-up period, images will also be collected and assessed as an alternative. If the experimental group can maintain or even improve skeletal muscle mass and can be reflected in blood tests and prognosis, the result may be able to apply on cancer treatment and disease follow-up.

This project can determine the baseline skeletal muscle mass of Head and Neck cancer patients and hope to monitor its changes after exercise training through imaging tools and find the most suitable imaging modalities. To understand the role of systemic inflammatory markers in sarcopenia, exercise training and oral cancer prognosis. This study hopes to serve as a basis and reference for clinical treatment selection, imaging follow up, interventional treatment or rehabilitation. The results of this research should benefit participants in Taiwan and abroad, and to promote the medical treatment and health of participants.

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, exercise training, and all the procedures in the trial.

Exclusion criteria

  • ECOG PS≥2
  • Participants with intolerance basic exercise training, or without 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 training
  • refure to do the trial procedures: exercise training, blood drawing and all the procedures in the trial.
  • can't get the data for the whole-body computed tomography

Treatment and study plan

HIIT only

Other

After CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three times a week and total 24-36 times.

HIIT & Record of physical activities at home.

Other

After CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three times in a week and total 24-36 times. And do the recording of physical activities at home.

Primary outcomes

  1. dual energy X-ray absorptiometry data

    Time frame: baseline,pre-iprocedure

    measure the whole-body skeletal muscle mass

  2. dual energy X-ray absorptiometry data

    Time frame: 3 month, during procedure

    measure the whole-body skeletal muscle mass

  3. dual energy X-ray absorptiometry data

    Time frame: 8 month, during procedure

    measure the whole-body skeletal muscle mass

Secondary outcomes

  1. Cardiopulmnary Exercise Test

    Time frame: baseline,pre-iprocedure

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

  2. Cardiopulmnary Exercise Test

    Time frame: 3 month, during procedure

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

  3. Cardiopulmnary Exercise Test

    Time frame: 8 month, during procedure

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

Other outcomes

  1. computed tomography (CT)

    Time frame: baseline,pre-iprocedure

    check toumor condition and another image modality for skeletal muscle mass evaluation

  2. computed tomography (CT)

    Time frame: 8 month, during procedure

    check toumor condition and another image modality for skeletal muscle mass evaluation

  3. blood data-myostatin

    Time frame: 3 month, during procedure

    inflammatory markers

  4. blood data-myostatin

    Time frame: 8 month, during procedure

    inflammatory markers

  5. blood data-IL-10

    Time frame: 3 month, during procedure

    inflammatory markers

  6. blood data-IL-10

    Time frame: 8 month, during procedure

    inflammatory markers

  7. blood data-IL-1β

    Time frame: 3 month, during procedure

    inflammatory markers

  8. blood data-IL-1β

    Time frame: 8 month, during procedure

    inflammatory markers

  9. blood data-IL-15

    Time frame: 3 month, during procedure

    inflammatory markers

  10. blood data-IL-15

    Time frame: 8 month, during procedure

    inflammatory markers

Study contacts

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

Chia-Hsun Hsieh, PhD

CONTACT

[email protected]

0975366137

Shao-Chung Wang, PhD

CONTACT

[email protected]

0978835190

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

(Health Promotion) Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in Head and Neck Cancer Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

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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