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

NCT06666881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

Interventions

OTHER

HIIT only

After CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three times a week and total 24-36 times.

OTHER

HIIT & Record of physical activities at home.

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Shao-Chung Wang · New Taipei City TuCheng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666881 on ClinicalTrials.gov