ClinicalTrials.gg
RecruitingNCT06666881Updated Sep 17, 2026

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

An interventional study of HIIT only and HIIT & Record of physical activities at home. in Head and Neck Cancer and Skeletal Muscle, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2023, registered Oct 2024).
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Head and Neck Neoplasms by Chang Gung Memorial Hospital — 7 open to participants now, 7 under way, none of them phase 3. Head and Neck Neoplasms · Chang Gung Memorial Hospital.

Started
2023
with 1 other
No phase
7 of 22
5 open now
Registered
19th of 22
by date

Among the 22 studies in Head and Neck Neoplasms by Chang Gung Memorial Hospital, this one is one of 2 that started in 2023, is one of 7 with no phase, and was the 19th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Observational13 · 1 open
No phasethis study7 · 5 open
Phase 22 · 1 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2023.

Size and results

Median enrollment 92 across the 9 interventional studies, 150 across the 13 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Head and Neck Neoplasms by Chang Gung Memorial Hospital, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Head and Neck Cancer
  • Skeletal Muscle

Keywords

  • exercise training
  • dual energy X-ray absorptiometry
  • sarcopenia
  • head and neck cancer
04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
280 participants (estimated)

Study arms

  • No intervention
    control

    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

  • OtherHIIT only

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

  • OtherHIIT & 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.

06

What researchers measure

Primary outcomes

  1. dual energy X-ray absorptiometry data

    measure the whole-body skeletal muscle mass

    Time frame: baseline,pre-iprocedure

  2. dual energy X-ray absorptiometry data

    measure the whole-body skeletal muscle mass

    Time frame: 3 month, during procedure

  3. dual energy X-ray absorptiometry data

    measure the whole-body skeletal muscle mass

    Time frame: 8 month, during procedure

  4. dual energy X-ray absorptiometry data

    measure the whole-body skeletal muscle mass

    Time frame: 11 month, during procedure

Secondary outcomes

  1. Cardiopulmnary Exercise Test

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

    Time frame: baseline,pre-iprocedure

  2. Cardiopulmnary Exercise Test

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

    Time frame: 3 month, during procedure

  3. Cardiopulmnary Exercise Test

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

    Time frame: 8 month, during procedure

  4. Cardiopulmnary Exercise Test

    record the VO2% of participants by doing the exercise test to assess the cardiopulmnary funtion before and after excercise training

    Time frame: 11 month, during procedure

Other outcomes

  1. computed tomography (CT)

    check toumor condition and another image modality for skeletal muscle mass evaluation

    Time frame: baseline,pre-iprocedure

  2. computed tomography (CT)

    check toumor condition and another image modality for skeletal muscle mass evaluation

    Time frame: 8 month, during procedure

  3. blood data-myostatin

    inflammatory markers

    Time frame: 3 month, during procedure

  4. blood data-myostatin

    inflammatory markers

    Time frame: 8 month, during procedure

  5. blood data-IL-10

    inflammatory markers

    Time frame: 3 month, during procedure

  6. blood data-IL-10

    inflammatory markers

    Time frame: 8 month, during procedure

  7. blood data-IL-1β

    inflammatory markers

    Time frame: 3 month, during procedure

  8. blood data-IL-1β

    inflammatory markers

    Time frame: 8 month, during procedure

  9. blood data-IL-15

    inflammatory markers

    Time frame: 3 month, during procedure

  10. blood data-IL-15

    inflammatory markers

    Time frame: 8 month, during procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Sep 2027, 51 months after the start.

Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 51 months is above that.

Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2024
First posted
Oct 31, 2024
StartActual
Jun 6, 2023
Primary completionEst.
Sep 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06666881
Responsible party
Wang Shao Chung, PhD (Professor Attending Physicians, Chang Gung Memorial Hospital) — Principal investigator
First posted
Oct 31, 2024
Start date
Jun 6, 2023
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Shao-Chung Wang, PhD
Contact
seanscwang@cgmh.org.tw
0978835190
Chia-Hsun Hsieh, PhD
Contact
wisdom5000@cgmh.org.tw
0975366137
Shao-Chung Wang
study director · New Taipei City TuCheng Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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