New Taipei City TuCheng Hospital
New Taipei City, Taiwan
Location status: Recruiting
NCT Number: NCT06666881
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.
Interested in participating?
Request Info20 year–80 year
All sexes
Interventional
Not applicable
New Taipei City, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three times a week and total 24-36 times.
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.
Time frame: baseline,pre-iprocedure
measure the whole-body skeletal muscle mass
Time frame: 3 month, during procedure
measure the whole-body skeletal muscle mass
Time frame: 8 month, during procedure
measure the whole-body skeletal muscle mass
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
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
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
Time frame: baseline,pre-iprocedure
check toumor condition and another image modality for skeletal muscle mass evaluation
Time frame: 8 month, during procedure
check toumor condition and another image modality for skeletal muscle mass evaluation
Time frame: 3 month, during procedure
inflammatory markers
Time frame: 8 month, during procedure
inflammatory markers
Time frame: 3 month, during procedure
inflammatory markers
Time frame: 8 month, during procedure
inflammatory markers
Time frame: 3 month, during procedure
inflammatory markers
Time frame: 8 month, during procedure
inflammatory markers
Time frame: 3 month, during procedure
inflammatory markers
Time frame: 8 month, during procedure
inflammatory markers
Contact information is provided by the study sponsor or research team.
Chia-Hsun Hsieh, PhD
CONTACT
Shao-Chung Wang, PhD
CONTACT
Chang Gung Memorial Hospital
Other
(Health Promotion) Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in Head and Neck Cancer Patients
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