Clinical trial · Interventional
Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients
(Health Promotion) Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in Head and Neck Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Skeletal Muscle | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIIT only | Other | — | UNRESOLVED |
| HIIT & Record of physical activities at home. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control
- description
- No Intervention: Head and Neck patients after CCRT treatment. After CCRT treatment, participants keep follow the skeletal muscle mass evaluation
- type
- EXPERIMENTAL
- label
- experimental
- description
- 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.
- interventionNames
- Other: HIIT only
- Other: HIIT & Record of physical activities at home.
Primary outcomes (4)
- measure
- dual energy X-ray absorptiometry data
- timeFrame
- baseline,pre-iprocedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDTieland 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