Clinical trial NCT06666881: Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients
Official title: (Health Promotion) Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Skeletal Muscle
Keywords: exercise training
dual energy X-ray absorptiometry
sarcopenia
head and neck cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project can determine the baseline skeletal muscle mass of Head and Neck cancer patients and hopes 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 Head and Neck cancer 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 patients in Taiwan and abroad, and to promote the medical treatment and health of patients.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: dual energy X-ray absorptiometry data
timeFrame: baseline,pre-iprocedure
measure: dual energy X-ray absorptiometry data
timeFrame: 3 month, during procedure
measure: dual energy X-ray absorptiometry data
timeFrame: 8 month, during procedure
Secondary outcomes:
measure: Cardiopulmnary Exercise Test
timeFrame: baseline,pre-iprocedure
measure: Cardiopulmnary Exercise Test
timeFrame: 3 month, during procedure
measure: Cardiopulmnary Exercise Test
timeFrame: 8 month, during procedure
Other outcomes:
measure: computed tomography (CT)
timeFrame: baseline,pre-iprocedure
measure: computed tomography (CT)
timeFrame: 8 month, during procedure
measure: blood data-myostatin
timeFrame: 3 month, during procedure
measure: blood data-myostatin
timeFrame: 8 month, during procedure
measure: blood data-IL-10
timeFrame: 3 month, during procedure
measure: blood data-IL-10
timeFrame: 8 month, during procedure
measure: blood data-IL-1β
timeFrame: 3 month, during procedure
measure: blood data-IL-1β
timeFrame: 8 month, during procedure
measure: blood data-IL-15
timeFrame: 3 month, during procedure
measure: blood data-IL-15
timeFrame: 8 month, during procedure
Locations:
city: New Taipei City
country: Taiwan
facility: New Taipei City TuCheng Hospital
Study officials:
affiliation: New Taipei City TuCheng Hospital
name: Shao-Chung Wang
role: STUDY_DIRECTOR
References:
citation: Tieland M, Trouwborst I, Clark BC. Skeletal muscle performance and ageing. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):3-19. doi: 10.1002/jcsm.12238. Epub 2017 Nov 19.