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Trial Title:
Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients
NCT ID:
NCT06666881
Condition:
Head and Neck Cancer
Skeletal Muscle
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
exercise training
dual energy X-ray absorptiometry
sarcopenia
head and neck cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This project can determine the baseline skeletal muscle mass of Head and Neck cancer
patients and hopes 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 Head and Neck cancer 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 patients in Taiwan and abroad, and to promote the medical
treatment and health of patients.
Primary purpose:
Other
Masking:
Single (Participant)
Masking description:
group random
Intervention:
Intervention type:
Other
Intervention name:
HIIT only
Description:
After CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three
times a week and total 24-36 times.
Arm group label:
experimental
Intervention type:
Other
Intervention name:
HIIT & Record of physical activities at home.
Description:
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.
Arm group label:
experimental
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥20
2. Pathology:Squamous cell carcinoma
3. Need CCRT treatment
4. ECOG PS<2
5. Agree with blood drawing, exercise training, and all the procedures in the trial.
Exclusion Criteria:
1. ECOG PS≥2
2. Participants with intolerance basic exercise training, or without 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 training
5. refure to do the trial procedures: exercise training, blood drawing and all the
procedures in the trial.
6. can't get the data for the whole-body computed tomography
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
New Taipei City TuCheng Hospital
Address:
City:
New Taipei City
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
ShaoChung Wang, PhD
Phone:
0978835190
Email:
seanscwang@cgmh.org.tw
Start date:
June 6, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666881
