Lung CancerEMITORNCT01771796
Training Effects Following Resection Surgery in Patients With Lung Cancer
A study testing Aerobic and muscle resistance training in people with Lung Cancer, run by Parc de Salut Mar at 2 sites in Spain.
Trial summary
The purpose of this study is to determine the potential benefits resulting from a specific training on exercise tolerance and muscle function at the medium and long-time, as well as study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung cancer following resection surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Aerobic and muscle resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2012to Feb 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) age under 80 years.
- 2) patients with lung cancer stage I or II with surgery indication.
- 3) ability to understand and accept the trial procedures and to sign an informed consent.
Who cannot join
- 1) Serious cardiovascular, neuromuscular or metabolic conditions that could interfere with the results and/or interfere with the measurements.
- 2) complementary cancer treatment pre-or post-surgery.
- 3) treatment with drugs with potential effect on muscle structure and function (steroids, anabolic steroids, thyroid hormones and immunosuppressive).
- 4) cognitive or language barriers that impede the realization of the objective of the study and / or collaboration in the exercise program.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
1) Physical Medicine and Rehabilitation Dpt. Parc de Salut Mar.
Barcelona, Barcelona, 08003
2) Respiratory Medicine Dpt. Hospital de la Santa Creu i Sant Pau.
Barcelona, Barcelona, 08025
About this study
The purpose of this study is to determine the potential benefits resulting from a specific training on exercise tolerance and muscle function at the medium and long-time, as well as study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung cancer following resection surgery.
Read the detailed description
Surgical treatment of lung cancer (LC) leads to peripheral and respiratory muscle dysfunction (Mdys) with exercise limitation. This characteristic feature might be generated, not only for a reduced lung function, but also by deconditioning as well as respiratory and peripheral muscle dysfunction. It remains unknown the potential benefits resulting from a specific training and its effects on plasmatic mediators.
Chronic diseases are the leading cause of morbidity and mortality worldwide and is known that regular exercise has a beneficial effect on most of them. Many studies have shown the benefit of exercise in patients diagnosed with cancer, especially breast and colorectal cancer, even during active phases of specific treatment, however few studies refers to possible benefit of exercise in patients with lung cancer following surgical resection. Lung cancer is one of the most common cancers in Spain, the second in the general population and the first if we refer exclusively to the male population. Not only it is a common type of cancer, but also presents a high mortality with a survival rate at 5 years of approximately 12%. However, survival improves significantly in stage I (60-80% at 5 years) and progressively worse until stage IV (<5% at 5 years). Surgery is the treatment of choice for lung cancer in stages I and IIa. Despite the good results in terms of survival, it is not free of side effects. Depending on the extent of lung resection, it may result in functional limitations and impact on the patients' quality of life. Pulmonary lobectomy entails a significant reduction of the functional reserve: impaired lung function (FEV1 of 15%) and reduced exercise capacity (16% in the shuttle test). In contrast, in the pneumonectomy, reduced pulmonary function is disproportionately higher (FEV1 of 35%) in comparison with the exercise limitation (23%). To date we have no knowledge of studies that have specifically evaluated the effects of exercise training in these patients.
Dysfunction of the diaphragm and other respiratory muscles, prevalent in COPD (chronic obstructive pulmonary disease) patients, has important clinical implications. It associates with susceptibility to hypercapnic ventilatory failure, ineffective cough, and even higher incidence of repeated hospital admissions and mortality. Therefore, respiratory muscle weakness described in some patients justifies the need to train respiratory muscles because there is no general exercise (bicycle, legs, arms) able to induce an overload enough to achieve training effect on respiratory muscles. Since a large proportion of lung cancer patients also suffer from COPD, endurance and strength of respiratory muscles are expected to be reduced. Moreover, after lobectomy patients have some degree of peripheral muscle deconditioning, which could be linked to the loss of reserve function, but also the relative rest. Although muscle training has been successfully used to restore function in patients with various chronic diseases and frailty, there is little evidence on the beneficial effects of muscle training in patients after lung cancer surgery.
Many studies have related the insulin-like growth factor I (IGF-I) and its major regulatory proteins, Insulin-like growth factor binding protein (IGFBP-3) with various malignancies, including lung cancer. In healthy subjects with sedentary lifestyle, caloric diet leads to obesity and alterations of hormonal, metabolic and inflammatory modulate carcinogenesis. These disorders include chronic hyperinsulinemia, elevated plasma IGF-I, plasma enhanced bioavailability and increased steroid sex hormones of systemic inflammation markers. Physical exercise, in addition to its cardiovascular effects and/or muscular strength and endurance produces a response on plasmatic levels of IGF-I and IGFBP-3. This variability has been justified, in most cases, depending on type, intensity and/or duration of the exercise performed.
- Conditions
- Lung Cancer
- Being tested
- Aerobic and muscle resistance training
- Keywords
- Exercise; lung cancer; aerobic training, resistance training; respiratory muscle training
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and muscle resistance trainingBehavioural
After having been allocated randomly to one of the two groups, patients of Intervention Group are encouraged to follow a training program (aerobic and endurance muscle training) during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and muscle resistance training | Experimental | Not described Receives: Behavioral: Aerobic and muscle resistance training |
| Usual care group | No intervention | All patients (intervention and usual care group) are patients with lung cancer who underwent a resection surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak) determined by a cardiopulmonary effort test (CPET)
VO2peak is determined by a standardised incremental exercise test. Subjects are instructed to pedal in an electrically braked cycloergometer and are encouraged to continue until they are not able to sustain the target frequency (55-65 rpm). Loads are increased by 25 watts every 2 minutes. Different ventilatory, cardiovascular, metabolic and oxygenation variables are monitored throughout the test using a calibrated exercise system, a standard electrocardiograph, an automatic sphygmomanometer and a finger probe connected to the aforementioned digital recorder. Normal values published by Jones et al are used as the reference for physiological parameters, except for the maximum heart rate which was calculated from a standard equation published by Wassermann et al.
Measured: 3 times a week during 8 weeks
Secondary outcomes (3)
Other effort parameters determined by the CPET
Measured: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)
Peripheral muscle strength
Measured: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)
Plasmatic levels of sMICA, IGF-I, IGFBP-3.
Measured: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Sant Pau
- Responsible party
- Principal investigator, Esther Marco Navarro, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771796
- Sponsor's protocol ID
- PSM/RHB/CR/12
- Acronym
- EMITOR
- Status last verified
- Feb 2016
- First submitted
- 10 Jan 2013
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Effects Following Resection Surgery in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT01771796
- Acronym / sponsor ID
- EMITOR / PSM/RHB/CR/12
- Conditions
- Lung Cancer
- Keywords
- Exercise; lung cancer; aerobic training, resistance training; respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Hospital de Sant Pau
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Jan 2013 (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.
The purpose of this study is to determine the potential benefits resulting from a specific training on exercise tolerance and muscle function at the medium and long-time, as well as study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung cancer following resection surgery.
Detailed description
Surgical treatment of lung cancer (LC) leads to peripheral and respiratory muscle dysfunction (Mdys) with exercise limitation. This characteristic feature might be generated, not only for a reduced lung function, but also by deconditioning as well as respiratory and peripheral muscle dysfunction. It remains unknown the potential benefits resulting from a specific training and its effects on plasmatic mediators.
Chronic diseases are the leading cause of morbidity and mortality worldwide and is known that regular exercise has a beneficial effect on most of them. Many studies have shown the benefit of exercise in patients diagnosed with cancer, especially breast and colorectal cancer, even during active phases of specific treatment, however few studies refers to possible benefit of exercise in patients with lung cancer following surgical resection. Lung cancer is one of the most common cancers in Spain, the second in the general population and the first if we refer exclusively to the male population. Not only it is a common type of cancer, but also presents a high mortality with a survival rate at 5 years of approximately 12%. However, survival improves significantly in stage I (60-80% at 5 years) and progressively worse until stage IV (<5% at 5 years). Surgery is the treatment of choice for lung cancer in stages I and IIa. Despite the good results in terms of survival, it is not free of side effects. Depending on the extent of lung resection, it may result in functional limitations and impact on the patients' quality of life. Pulmonary lobectomy entails a significant reduction of the functional reserve: impaired lung function (FEV1 of 15%) and reduced exercise capacity (16% in the shuttle test). In contrast, in the pneumonectomy, reduced pulmonary function is disproportionately higher (FEV1 of 35%) in comparison with the exercise limitation (23%). To date we have no knowledge of studies that have specifically evaluated the effects of exercise training in these patients.
Dysfunction of the diaphragm and other respiratory muscles, prevalent in COPD (chronic obstructive pulmonary disease) patients, has important clinical implications. It associates with susceptibility to hypercapnic ventilatory failure, ineffective cough, and even higher incidence of repeated hospital admissions and mortality. Therefore, respiratory muscle weakness described in some patients justifies the need to train respiratory muscles because there is no general exercise (bicycle, legs, arms) able to induce an overload enough to achieve training effect on respiratory muscles. Since a large proportion of lung cancer patients also suffer from COPD, endurance and strength of respiratory muscles are expected to be reduced. Moreover, after lobectomy patients have some degree of peripheral muscle deconditioning, which could be linked to the loss of reserve function, but also the relative rest. Although muscle training has been successfully used to restore function in patients with various chronic diseases and frailty, there is little evidence on the beneficial effects of muscle training in patients after lung cancer surgery.
Many studies have related the insulin-like growth factor I (IGF-I) and its major regulatory proteins, Insulin-like growth factor binding protein (IGFBP-3) with various malignancies, including lung cancer. In healthy subjects with sedentary lifestyle, caloric diet leads to obesity and alterations of hormonal, metabolic and inflammatory modulate carcinogenesis. These disorders include chronic hyperinsulinemia, elevated plasma IGF-I, plasma enhanced bioavailability and increased steroid sex hormones of systemic inflammation markers. Physical exercise, in addition to its cardiovascular effects and/or muscular strength and endurance produces a response on plasmatic levels of IGF-I and IGFBP-3. This variability has been justified, in most cases, depending on type, intensity and/or duration of the exercise performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic and muscle resistance training | Experimental | Behavioral: Aerobic and muscle resistance training |
| Usual care group | No intervention | –All patients (intervention and usual care group) are patients with lung cancer who underwent a resection surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) age under 80 years.
- 2) patients with lung cancer stage I or II with surgery indication.
- 3) ability to understand and accept the trial procedures and to sign an informed consent.
Key exclusion criteria (4 listed)
- 1) Serious cardiovascular, neuromuscular or metabolic conditions that could interfere with the results and/or interfere with the measurements.
- 2) complementary cancer treatment pre-or post-surgery.
- 3) treatment with drugs with potential effect on muscle structure and function (steroids, anabolic steroids, thyroid hormones and immunosuppressive).
- 4) cognitive or language barriers that impede the realization of the objective of the study and / or collaboration in the exercise program.
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 |
|---|---|---|
| Aerobic and muscle resistance trainingAfter having been allocated randomly to one of the two groups, patients of Intervention Group are encouraged to follow a training program (aerobic and endurance muscle training) during 8 weeks. | Behavioural | Aerobic and muscle resistance training |
Primary outcome
Peak oxygen uptake (VO2peak) determined by a cardiopulmonary effort test (CPET)
Time frame: 3 times a week during 8 weeks
VO2peak is determined by a standardised incremental exercise test. Subjects are instructed to pedal in an electrically braked cycloergometer and are encouraged to continue until they are not able to sustain the target frequency (55-65 rpm). Loads are increased by 25 watts every 2 minutes. Different ventilatory, cardiovascular, metabolic and oxygenation variables are monitored throughout the test using a calibrated exercise system, a standard electrocardiograph, an automatic sphygmomanometer and a finger probe connected to the aforementioned digital recorder. Normal values published by Jones et al are used as the reference for physiological parameters, except for the maximum heart rate which was calculated from a standard equation published by Wassermann et al.
3 secondary outcomes
Other effort parameters determined by the CPET
Time frame: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)
Peripheral muscle strength
Time frame: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)
Plasmatic levels of sMICA, IGF-I, IGFBP-3.
Time frame: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)
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 17 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and muscle resistance training in people with Lung Cancer, run by Parc de Salut Mar at 2 sites in Spain.
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 3 inclusion and 4 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Peak oxygen uptake (VO2peak) determined by a cardiopulmonary effort test (CPET) (time frame: 3 times a week during 8 weeks). 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 17 Feb 2016.