CancerNCT06203301
The Relationships of Resistance Exercise, Walking, Myokine Secretion, Sarcopenia, Muscle Loss, Quality of Life, and Predictors in Cancer Patients Receiving Chemoradiotheray
A study testing resistance exercise and walking in people with Cancer, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Cancer is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- resistance exercise and walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Dec 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients receiving chemoradiotherap
- age 20-70 years old
- participants who are available for doing resistance exercise and/or walking after physical assessment by physician
- education level \>=elementary school
Who cannot join
- Participants can't speak Mandarin, Taiwanese, or Hakka language.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, Taipei Taiwan, 110301
Hsiu Ting Tsai, 886-2-27361661 ext. 6337, hsiuting@tmu.edu.tw;tsaihsiuting@yahoo.com.tw
Chai Hsuan Sun, 886+928894620, m432110019@tmu.edu.tw
About this study
Cancer is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of hematological toxicity and nonhematological toxicity, decreased quality of life and survival rate. It was reported that skeletal muscle can secretion of myokines, which contribute to muscle synthesis, growth, repair, or atrophy. Investigators suggest that detection of blood concentration of myokines and sarcopenia-related predictors can early detection potential individuals who are susceptibility to sarcopenia in cervical cancer patients receiving chemoradiotherapy. Also, resistance exercise was demonstrated to improve muscle mass, muscle strength, physical performance, and sarcopenia. Investigators suggest that resistance exercise can prevent cervical cancer patients from sarcopenia and improve quality of life through regulation the concentration of myokines. However, there was no study has been investigated their relationships. Therefore, investigators will conduct a randomized controlled trial study to estimate (1) the effect of resistance exercise, walking on regulation myokine secretion, improving skeletal muscle mass, muscle strength, physical performance, sarcopenia, and quality of life in cancer receiving chemoradiotherapy; (2) myokine level, muscle mass, muscle strength, physical performance, and sarcopenia incidence in cancer patients before and after receiving chemoradiotherapy.
Read the detailed description
Cancer is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of hematological toxicity and nonhematological toxicity, decreased quality of life and survival rate. It was reported that skeletal muscle can secretion of myokines, which contribute to muscle synthesis, growth, repair, or atrophy. Investigators suggest that detection of blood concentration of myokines and sarcopenia-related predictors can early detection potential individuals who are susceptibility to sarcopenia in cervical cancer patients receiving chemoradiotherapy. Also, resistance exercise was demonstrated to improve muscle mass, muscle strength, physical performance, and sarcopenia. Investigators suggest that resistance exercise can prevent cervical cancer patients from sarcopenia and improve quality of life through regulation the concentration of myokines. However, there was no study has been investigated their relationships. Therefore, investigators will conduct a randomized controlled trial study to estimate (1) the effect of resistance exercise, walking on regulation myokine secretion, improving skeletal muscle mass, muscle strength, physical performance, sarcopenia, and quality of life in cancer receiving chemoradiotherapy; (2) myokine level, muscle mass, muscle strength, physical performance, and sarcopenia incidence in cancer patients before and after receiving chemoradiotherapy.
- Conditions
- Cancer
- Being tested
- resistance exercise and walking
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance exercise and walkingBehavioural
After receiving the cases, they were divided into 4 groups by random allocation:
- Control group: No exercise intervention measures are performed, and the patients carry out their daily lives according to their past living habits.
- Resistance exercise group: Resistance exercise training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. The patients are given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. Afterwards, the patient is asked to regularly perform resistance exercise on his own for at least 1 year.
- Walking group: Walking training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. They should walk continuously for 15 minutes at least twice a day and continue walking at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walk
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No exercise intervention measures will be implemented. The patient will carry out daily life according to his past living habits and continue to be followed for at least one year. |
| resistance exercise group | Experimental | Resistance exercise training begins before the patient undergoes concurrent chemoradiotherapy, radiotherapy, or chemotherapy. The patients were given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. After that, the patient is asked to regularly perform resistance exercise for at least 1 year. Receives: Behavioral: resistance exercise and walking |
| walking group | Experimental | Walking training begins before the patient undergoes simultaneous radiochemotherapy, radiation therapy, or chemotherapy, and requires continuous walking for 15 minutes at least twice a day and at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walking training. After that, ask the patient to walk regularly for at least 1 year. Receives: Behavioral: resistance exercise and walking |
| resistance exercise and walking group | Experimental | Before patients receive concurrent chemoradiotherapy, radiotherapy, or chemotherapy, they are given resistance exercise training and walking training for 12 consecutive weeks. After that, the patient is asked to regularly perform resistance exercise and walking for at least 1 year. Receives: Behavioral: resistance exercise and walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical functional performance
This study plans to use the 5-time stand-up-sit test to assess physical functional performance. Five stand-up and sit-down tests lasting more than or equal to 12 seconds indicate that the patient's physical function performance is reduced.During the measurement, the patient is asked to sit on a chair about 40cm above the ground. The back of the chair is against the wall. The patient is asked to sit down against the back of the chair. The patient is asked to stand up. The patient is asked to do his best to stand up and stand upright five times continuously and without interruption. Sit down, keeping your hands folded on your chest.During the test, the patient stood up once and was asked to count the sounds. The test ended when the patient stood up for the fifth time.
Measured: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
muscle strength
Measuring the patient's muscle strength with a handgrip dynamometer(Hand Grip Strength, EH101, CAMYR, Guangdong)
Measured: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
muscle mass
In order to avoid radiation exposure when patients undergo testing and to facilitate repeated measurements, this research plan will use the Bioelectrical Impedance Analyzer (BIA) Inbody S10 to detect the skeletal muscle mass of the limbs of patients. The bioelectrical impedance analyzer is currently a commonly used analyzer for clinical measurement of body composition, using microcurrent to measure the human body.
Measured: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
the incidence of sarcopenia
The assessment of sarcopenia in this study uses the Asian Working Group for Sarcopenia (AWGS) diagnostic criteria as the criteria for screening sarcopenia, including: (1) low muscle strength: handgrip strength <28 kg for men, women <18 kg; (2) low physical performance: 5 stand-up and sit-down tests greater than or equal to 12 seconds; (3) loss of appendicular skeletal muscle mass (ASM): bioelectrical impedance analysis (BIA) men <7.0kg/m2, women <5.7kg/m2.
If the skeletal muscle mass of the limbs is reduced combined with weakened muscle strength or physical functional performance, it is called sarcopenia; if the skeletal muscle mass of the limbs is reduced, the muscle strength is weakened, and the physical functional performance is reduced at the same time, it is severe sarcopenia.
Measured: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
effectively improve their quality of life
This study uses the Functional Assessment of Cancer Therapy-General (FACT-G) to assess the quality of life of patients.
Measured: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
The concentration of muscle hormones in the blood of cancer patients undergoing treatment
The specimen is collected based on the principle of collecting 5 mL of venous blood. The blood is injected into a special biochemical test tube containing Lithium heparin, an anticoagulant, and mixed gently to avoid blood coagulation and hemolysis.
Centrifuge at 3500 rpm for 10 minutes, and separate the upper plasma for detection of muscle hormones in the blood, including: myonectin, irisin, decorin, fibroblast growth factor-21, interleukin-15, interleukin-6, myostatin, osteonectin, and brain-derived hormones.
Measured: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Dec 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203301
- Sponsor's protocol ID
- N202109030
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationships of Resistance Exercise, Walking, Myokine Secretion, Sarcopenia, Muscle Loss, Quality of Life, and Predictors in Cancer Patients Receiving Chemoradiotheray
- ClinicalTrials.gov ID
- NCT06203301
- Acronym / sponsor ID
- N202109030
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Jan 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.
Cancer is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of hematological toxicity and nonhematological toxicity, decreased quality of life and survival rate. It was reported that skeletal muscle can secretion of myokines, which contribute to muscle synthesis, growth, repair, or atrophy. Investigators suggest that detection of blood concentration of myokines and sarcopenia-related predictors can early detection potential individuals who are susceptibility to sarcopenia in cervical cancer patients receiving chemoradiotherapy. Also, resistance exercise was demonstrated to improve muscle mass, muscle strength, physical performance, and sarcopenia. Investigators suggest that resistance exercise can prevent cervical cancer patients from sarcopenia and improve quality of life through regulation the concentration of myokines. However, there was no study has been investigated their relationships. Therefore, investigators will conduct a randomized controlled trial study to estimate (1) the effect of resistance exercise, walking on regulation myokine secretion, improving skeletal muscle mass, muscle strength, physical performance, sarcopenia, and quality of life in cancer receiving chemoradiotherapy; (2) myokine level, muscle mass, muscle strength, physical performance, and sarcopenia incidence in cancer patients before and after receiving chemoradiotherapy.
Detailed description
Cancer is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of hematological toxicity and nonhematological toxicity, decreased quality of life and survival rate. It was reported that skeletal muscle can secretion of myokines, which contribute to muscle synthesis, growth, repair, or atrophy. Investigators suggest that detection of blood concentration of myokines and sarcopenia-related predictors can early detection potential individuals who are susceptibility to sarcopenia in cervical cancer patients receiving chemoradiotherapy. Also, resistance exercise was demonstrated to improve muscle mass, muscle strength, physical performance, and sarcopenia. Investigators suggest that resistance exercise can prevent cervical cancer patients from sarcopenia and improve quality of life through regulation the concentration of myokines. However, there was no study has been investigated their relationships. Therefore, investigators will conduct a randomized controlled trial study to estimate (1) the effect of resistance exercise, walking on regulation myokine secretion, improving skeletal muscle mass, muscle strength, physical performance, sarcopenia, and quality of life in cancer receiving chemoradiotherapy; (2) myokine level, muscle mass, muscle strength, physical performance, and sarcopenia incidence in cancer patients before and after receiving chemoradiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No exercise intervention measures will be implemented. The patient will carry out daily life according to his past living habits and continue to be followed for at least one year. |
| resistance exercise group | Experimental | Behavioral: resistance exercise and walkingResistance exercise training begins before the patient undergoes concurrent chemoradiotherapy, radiotherapy, or chemotherapy. The patients were given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. After that, the patient is asked to regularly perform resistance exercise for at least 1 year. |
| walking group | Experimental | Behavioral: resistance exercise and walkingWalking training begins before the patient undergoes simultaneous radiochemotherapy, radiation therapy, or chemotherapy, and requires continuous walking for 15 minutes at least twice a day and at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walking training. After that, ask the patient to walk regularly for at least 1 year. |
| resistance exercise and walking group | Experimental | Behavioral: resistance exercise and walkingBefore patients receive concurrent chemoradiotherapy, radiotherapy, or chemotherapy, they are given resistance exercise training and walking training for 12 consecutive weeks. After that, the patient is asked to regularly perform resistance exercise and walking for at least 1 year. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients receiving chemoradiotherap
- age 20-70 years old
- participants who are available for doing resistance exercise and/or walking after physical assessment by physician
- education level \&gt;=elementary school
Key exclusion criteria (1 listed)
- Participants can't speak Mandarin, Taiwanese, or Hakka language.
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 |
|---|---|---|
| resistance exercise and walkingAfter receiving the cases, they were divided into 4 groups by random allocation: 1. Control group: No exercise intervention measures are performed, and the patients carry out their daily lives according to their past living habits. 2. Resistance exercise group: Resistance exercise training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. The patients are given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. Afterwards, the patient is asked to regularly perform resistance exercise on his own for at least 1 year. 3. Walking group: Walking training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. They should walk continuously for 15 minutes at least twice a day and continue walking at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walk | Behavioural | resistance exercise and walking group, resistance exercise group, walking group |
Primary outcome
physical functional performance
Time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
This study plans to use the 5-time stand-up-sit test to assess physical functional performance. Five stand-up and sit-down tests lasting more than or equal to 12 seconds indicate that the patient's physical function performance is reduced.During the measurement, the patient is asked to sit on a chair about 40cm above the ground. The back of the chair is against the wall. The patient is asked to sit down against the back of the chair. The patient is asked to stand up. The patient is asked to do his best to stand up and stand upright five times continuously and without interruption. Sit down, keeping your hands folded on your chest.During the test, the patient stood up once and was asked to count the sounds. The test ended when the patient stood up for the fifth time.
muscle strength
Time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
Measuring the patient's muscle strength with a handgrip dynamometer(Hand Grip Strength, EH101, CAMYR, Guangdong)
muscle mass
Time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
In order to avoid radiation exposure when patients undergo testing and to facilitate repeated measurements, this research plan will use the Bioelectrical Impedance Analyzer (BIA) Inbody S10 to detect the skeletal muscle mass of the limbs of patients. The bioelectrical impedance analyzer is currently a commonly used analyzer for clinical measurement of body composition, using microcurrent to measure the human body.
the incidence of sarcopenia
Time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
The assessment of sarcopenia in this study uses the Asian Working Group for Sarcopenia (AWGS) diagnostic criteria as the criteria for screening sarcopenia, including: (1) low muscle strength: handgrip strength <28 kg for men, women <18 kg; (2) low physical performance: 5 stand-up and sit-down tests greater than or equal to 12 seconds; (3) loss of appendicular skeletal muscle mass (ASM): bioelectrical impedance analysis (BIA) men <7.0kg/m2, women <5.7kg/m2. If the skeletal muscle mass of the limbs is reduced combined with weakened muscle strength or physical functional performance, it is called sarcopenia; if the skeletal muscle mass of the limbs is reduced, the muscle strength is weakened, and the physical functional performance is reduced at the same time, it is severe sarcopenia.
effectively improve their quality of life
Time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
This study uses the Functional Assessment of Cancer Therapy-General (FACT-G) to assess the quality of life of patients.
The concentration of muscle hormones in the blood of cancer patients undergoing treatment
Time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
The specimen is collected based on the principle of collecting 5 mL of venous blood. The blood is injected into a special biochemical test tube containing Lithium heparin, an anticoagulant, and mixed gently to avoid blood coagulation and hemolysis. Centrifuge at 3500 rpm for 10 minutes, and separate the upper plasma for detection of muscle hormones in the blood, including: myonectin, irisin, decorin, fibroblast growth factor-21, interleukin-15, interleukin-6, myostatin, osteonectin, and brain-derived hormones.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance exercise and walking in people with Cancer, run by Taipei Medical University 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiu Ting Tsai (886-2-27361661 ext. 6337, hsiuting@tmu.edu.tw;tsaihsiuting@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical functional performance (time frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.