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

StatusRecruiting
PhaseNot applicable
Started2023-06-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Sep 30, 2025 → Sep 30, 2027
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Chang Gung Memorial Hospital

Amendment history

2026-09-18
notable
Enrollment increased: 60 → 280 participants
2026-08-06
critical
Study Status, Outcome Measures v1
Primary endpoint(s) modified3 to 4 entries
Wasdual energy X-ray absorptiometry data, dual energy X-ray absorptiometry data, dual energy X-ray absorptiometry data
Nowdual energy X-ray absorptiometry data, dual energy X-ray absorptiometry data, dual energy X-ray absorptiometry data, dual energy X-ray absorptiometry data
Primary completion pushed: 2025-09-30 → 2027-09-30
Secondary endpoints3 to 4 entries
Cardiopulmnary Exercise Test
2024-10-29
minor
Original filing
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.
Trial Details
NCT Number NCT06666881
Lead Sponsor Chang Gung Memorial Hospital
Conditions Head and Neck Cancer, Skeletal Muscle
Enrollment 280 participants
Start Date 2023-06-06
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-17