Head and Neck CancerNCT06666881
Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in HNSCC Patients
A study testing HIIT only and HIIT & Record of physical activities at home. in people with Head and Neck Cancer and Skeletal Muscle, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Head and Neck Cancer, Skeletal Muscle
- What is being tested?
- HIIT only and HIIT & Record of physical activities at home.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jun 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
New Taipei City TuCheng Hospital
New Taipei City
ShaoChung Wang, PhD, 0978835190, seanscwang@cgmh.org.tw
About this study
Official title: (Health Promotion) Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in Head and Neck Cancer Patients
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Skeletal Muscle
- Being tested
- HIIT only, HIIT & Record of physical activities at home.
- Keywords
- exercise training, dual energy X-ray absorptiometry, sarcopenia, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT onlyOther
After CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three times a week and total 24-36 times.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HIIT only; Other: HIIT & Record of physical activities at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Measured: baseline,pre-iprocedure
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Measured: 3 month, during procedure
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Measured: 8 month, during procedure
dual energy X-ray absorptiometry data
measure the whole-body skeletal muscle mass
Measured: 11 month, during procedure
Secondary outcomes (4)
Cardiopulmnary Exercise Test
record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training
Measured: baseline,pre-iprocedure
Cardiopulmnary Exercise Test
record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training
Measured: 3 month, during procedure
Cardiopulmnary Exercise Test
record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training
Measured: 8 month, during procedure
Cardiopulmnary Exercise Test
record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training
Measured: 11 month, during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start6 Jun 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shao Chung, PhD, Chang Gung Memorial Hospital
- Investigators
- Shao-Chung Wang, Study director, New Taipei City TuCheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666881
- Sponsor's protocol ID
- 202201325A3
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29151281
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Health Promotion) Skeletal Muscle Mass Changes on Images for Prediction of Prognosis After Exercise Training in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT06666881
- Acronym / sponsor ID
- 202201325A3
- Conditions
- Head and Neck Cancer, Skeletal Muscle
- Keywords
- exercise training, dual energy X-ray absorptiometry, sarcopenia, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: HIIT only, Other: HIIT & Record of physical activities at home.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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT onlyAfter CCRT treatment 4-5 week, arrange participants do the HIIT exercise for two to three times a week and total 24-36 times. | Other | experimental |
| 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. | Other | experimental |
Primary outcome
dual energy X-ray absorptiometry data
Time frame: baseline,pre-iprocedure
measure the whole-body skeletal muscle mass
dual energy X-ray absorptiometry data
Time frame: 3 month, during procedure
measure the whole-body skeletal muscle mass
dual energy X-ray absorptiometry data
Time frame: 8 month, during procedure
measure the whole-body skeletal muscle mass
dual energy X-ray absorptiometry data
Time frame: 11 month, during procedure
measure the whole-body skeletal muscle mass
4 secondary outcomes
Cardiopulmnary Exercise Test
Time frame: baseline,pre-iprocedure
Cardiopulmnary Exercise Test
Time frame: 3 month, during procedure
Cardiopulmnary Exercise Test
Time frame: 8 month, during procedure
Cardiopulmnary Exercise Test
Time frame: 11 month, during procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 29151281Tieland 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.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shao-Chung Wang study director
New Taipei City TuCheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT only and HIIT & Record of physical activities at home. in people with Head and Neck Cancer and Skeletal Muscle, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shao-Chung Wang, PhD (0978835190, seanscwang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dual energy X-ray absorptiometry data (time frame: baseline,pre-iprocedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06666881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.