Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
NCT06666881

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

Led by Chang Gung Memorial Hospital · Updated on 2024-10-31

60

Participants Needed

1

Research Sites

225 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Diagnosed with squamous cell carcinoma
  • Requires concurrent chemoradiotherapy (CCRT) treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status less than 2
  • Agree to blood drawing, exercise training, and all trial procedures
Not Eligible

You will not qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
  • Unable to tolerate basic exercise training or no CCRT treatment
  • Mental illness or medical conditions that may worsen with exercise training or are unmanageable
  • Any medical condition unsuitable for exercise training
  • Refusal to participate in trial procedures including exercise training and blood drawing
  • Unable to obtain whole-body computed tomography data

AI-Screening

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Trial Site Locations

Total: 1 location

1

New Taipei City TuCheng Hospital

New Taipei City, Taiwan

Actively Recruiting

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Research Team

S

Shao-Chung Wang, PhD

CONTACT

C

Chia-Hsun Hsieh, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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