Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥20
Pathology:Squamous cell carcinoma
Need CCRT treatment
ECOG PS<2
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HIIT only
Other interventionAfter 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 interventionAfter 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.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: controlNo intervention 0 interventions
Group B: experimentalExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Time frame
baseline,pre-iprocedure2
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Time frame
3 month, during procedure3
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Time frame
8 month, during procedure4
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Time frame
11 month, during procedureSecondary outcomes
1
Cardiopulmnary Exercise Test
record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training
Time frame
baseline,pre-iprocedure2
Cardiopulmnary Exercise Test
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 procedure3
Cardiopulmnary Exercise Test
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 procedure4
Cardiopulmnary Exercise Test
record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training
Time frame
11 month, during procedureOther outcomes
1
computed tomography (CT)
check toumor condition and another image modality for skeletal muscle mass evaluation
Time frame
baseline,pre-iprocedure2
computed tomography (CT)
check toumor condition and another image modality for skeletal muscle mass evaluation
Time frame
8 month, during procedure3
blood data-myostatin
inflammatory markers
Time frame
3 month, during procedure4
blood data-myostatin
inflammatory markers
Time frame
8 month, during procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov