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

NCT06666881 | Recruiting

• 1 other identifier: 202201325A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Skeletal Muscle

Keywords

exercise training; dual energy X-ray absorptiometry; sarcopenia; head and neck cancer

Outcome Measures

Primary Outcomes (3)

• dual energy X-ray absorptiometry data

  measure the whole-body skeletal muscle mass

  baseline,pre-iprocedure

• dual energy X-ray absorptiometry data

  measure the whole-body skeletal muscle mass

  3 month, during procedure

• dual energy X-ray absorptiometry data

  measure the whole-body skeletal muscle mass

  8 month, during procedure

Secondary Outcomes (3)

• Cardiopulmnary Exercise Test

  baseline,pre-iprocedure

• Cardiopulmnary Exercise Test

  3 month, during procedure

• Cardiopulmnary Exercise Test

  8 month, during procedure

Other Outcomes (10)

• computed tomography (CT)

  baseline,pre-iprocedure

• computed tomography (CT)

  8 month, during procedure

• blood data-myostatin

  3 month, during procedure

Study Arms (2)

control

NO INTERVENTION

No Intervention: Head and Neck patients after CCRT treatment. After CCRT treatment, participants keep follow the skeletal muscle mass evaluation

experimental

EXPERIMENTAL

Experimental: Head and Neck patients after CCRT treatment with exercise training. After CCRT treatment 4-5 week, arrange participants do the exercise training for patient. Two to three times a week ,total 24-36 times. Participants keep follow the skeletal muscle mass evaluation.

Other: HIIT only; Other: HIIT & Record of physical activities at home.

Interventions

HIIT only OTHER

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

experimental

HIIT & Record of physical activities at home. OTHER

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.

experimental

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥20
• Pathology:Squamous cell carcinoma
• Need CCRT treatment
• ECOG PS\<2
• Agree with blood drawing, exercise training, and all the procedures in the trial.

You may not qualify if:

• ECOG PS≥2
• Participants with intolerance basic exercise training, or without CCRT treatment
• Mental illness or any medical illness or concurrent illness that may be aggravated by exercise training or unmanageable
• Any medical condition that unsuitable for exercise training
• refure to do the trial procedures: exercise training, blood drawing and all the procedures in the trial.
• can't get the data for the whole-body computed tomography

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

New Taipei City TuCheng Hospital

New Taipei City, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 29151281 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Shao-Chung Wang

  New Taipei City TuCheng Hospital

  STUDY DIRECTOR

Central Study Contacts

Shao-Chung Wang, PhD

CONTACT

0978835190; seanscwang@cgmh.org.tw

Chia-Hsun Hsieh, PhD

CONTACT

0975366137; wisdom5000@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: group random
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Attending Physicians

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 31, 2024
• Study Start: June 6, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)