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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Skeletal Muscle

• Registration Number: NCT06666881
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2023-06-06
• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
dual energy X-ray absorptiometry data	8 month, during procedure	measure the whole-body skeletal muscle mass

Secondary Outcome Measures

Name	Time	Method
Cardiopulmnary Exercise Test	8 month, during procedure	record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

Trial Locations

Locations (1)

New Taipei City TuCheng Hospital; 🇨🇳 New Taipei City, Taiwan