Non-small-cell Lung CancerNCT01136083
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
A study testing Exercise training in people with Non-small-cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Aug 2012
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years
- Advanced NSCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Targeted therapy for at least 8 weeks
- Stable condition
Who cannot join
- Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
- Do not understand the verbal or written instructions
Trial locations and contacts
1 site in 1 country.
About this study
Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on
- circulating VEGF-A
- muscle growth and function
- Myostatin
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Exercise training, Usual care
- Keywords
- Tumor, Angiogenesis, Exercise training, VEGF, Myostatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Also called High intensity interval aerobic training
Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
Usual careOther
Also called Non-exercise or patient education
Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer. Receives: Behavioral: Exercise training |
| Control group | Active comparator | Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
Measured: 8 weeks after the start of the intervention
Secondary outcomes (8)
Imaging of muscle
Measured by MRS
Measured: 8 weeks and 16 weeks after the start of the intervention
Analysis of venous blood sample
Analysis of circulating VEGF-A and myostatin
Measured: 8 weeks andd 16 weeks after the start of the intervention
Quality of life
Measured by questionnaire
Measured: baseline, 8 weeks, 16 weeks
Exercise capacity
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
Measured: 16 weeks after the start of the intervention
Muscle function
Isokinetic muscle strength and endurance with Biodex
Measured: 8 weeks and 16 weeks after the start of the intervention
Physical activity
Measured with 7-day recall questionnaire
Measured: 8 weeks andd 16 weeks after the start of the intervention
Dietary intake
Measured with 24-hour recall questionnaire
Measured: 8 weeks andd 16 weeks after the start of the intervention
Body composition
Body mass index calculated with body weight and height
% body fat abd free-fat mass with BIA
Measured: 8 weeks andd 16 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ying-Tai Wu, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136083
- Sponsor's protocol ID
- 201003064R
- Status last verified
- Nov 2011
- First submitted
- 10 May 2010
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01136083
- Acronym / sponsor ID
- 201003064R
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- Tumor, Angiogenesis, Exercise training, VEGF, Myostatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Jun 2010 (estimated)
- 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 one of the leading health issues in this country and worldwide. Angiogenesis is an essential process for tumoral growth and metastasis. This process is dependent on the balance between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated with myostatin overexpression in cancer. Exercise training can depress tumor growth and suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and some animal studies. The purpose of this study is mainly to investigate the effects of exercise training on
- circulating VEGF-A
- muscle growth and function
- Myostatin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise trainingSubjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer. |
| Control group | Active comparator | Other: Usual careSubjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-75 years
- Advanced NSCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Targeted therapy for at least 8 weeks
- Stable condition
Key exclusion criteria (2 listed)
- Severe metastasis, cardiopulmonary or musculoskeletal conditions may affect participation in exercise
- Do not understand the verbal or written instructions
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 |
|---|---|---|
| Exercise trainingAlso: High intensity interval aerobic trainingSubjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer. | Behavioural | Exercise training |
| Usual careAlso: Non-exercise or patient educationSubjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital. | Other | Control group |
Primary outcome
Exercise capacity
Time frame: 8 weeks after the start of the intervention
Maximal oxygen consumption with Vmax229 Vastus lateral muscle oxygenation with NIRS
8 secondary outcomes
Imaging of muscle
Time frame: 8 weeks and 16 weeks after the start of the intervention
Analysis of venous blood sample
Time frame: 8 weeks andd 16 weeks after the start of the intervention
Quality of life
Time frame: baseline, 8 weeks, 16 weeks
Exercise capacity
Time frame: 16 weeks after the start of the intervention
Muscle function
Time frame: 8 weeks and 16 weeks after the start of the intervention
Physical activity
Time frame: 8 weeks andd 16 weeks after the start of the intervention
Dietary intake
Time frame: 8 weeks andd 16 weeks after the start of the intervention
Body composition
Time frame: 8 weeks andd 16 weeks after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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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.
Ying-Tai Wu, Ph.D principal investigator
National Taiwan University 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 Exercise training in people with Non-small-cell Lung Cancer, run by National Taiwan University 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 2 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: finished, as of the sponsor's last update on 13 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 8 weeks after the start of the intervention). 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 13 Aug 2013; AzTrials last refreshed its copy on 3 Nov 2026.