Training Effects Following Resection Surgery in Patients With Lung Cancer (EMITOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Parc de Salut Mar
Sponsor:
Collaborator:
Hospital de Sant Pau
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01771796
First received: January 10, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Lung Cancer
Behavioral: Aerobic and muscle resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Training Effects Following Resection Surgery in Patients With Lung Cancer

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Peak oxygen uptake (VO2peak) determined by a cardiopulmonary effort test (CPET) [ Time Frame: 3 times a week during 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Peripheral muscle strength [ Time Frame: Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic and muscle resistance training Behavioral: Aerobic and muscle resistance training
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.
No Intervention: Usual care group
All patients (intervention and usual care group) are patients with lung cancer who underwent a 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771796

Contacts
Contact: Josep Maria Muniesa, PhD +34 933674214 jmuniesa@parcdesalutmar.cat
Contact: Ester Marco, PhD +34 933674293 emarco@parcdesalutmar.cat

Locations
Spain
1) Physical Medicine and Rehabilitation Dpt. Parc de Salut Mar. Recruiting
Barcelona, Spain, 08003
Contact: Josep Maria Muniesa, PhD    +34 933674214    jmuniesa@parcdesalutmar.cat   
Contact: Ester Marco, PhD    +34 933674293    emarco@parcdesalutmar.cat   
Principal Investigator: Josep Maria Muniesa, PhD         
2) Respiratory Medicine Dpt. Hospital de la Santa Creu i Sant Pau. Recruiting
Barcelona, Spain, 08025
Contact: Maria Güell, PhD    +34636487779    mguellr@santpau.cat   
Sponsors and Collaborators
Parc de Salut Mar
Hospital de Sant Pau
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01771796     History of Changes
Other Study ID Numbers: PSM/RHB/CR/12
Study First Received: January 10, 2013
Last Updated: January 16, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
Exercise; lung cancer; aerobic training, resistance training; respiratory muscle training

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014