Clinical trial NCT04041297: Evaluation of NSCLC Patients' Oxygen Uptake On-kinetics at Cycle-ergometer During Prehabilitation
Official title: Evaluation of Non-Small Cell Lung Cancer Patients' Oxygen Uptake On-kinetics at Cycle-ergometer During Prehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Preoperative training
Prehabilitation
oxygen-uptake kinetics
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred in the ADIR Association for a preoperative pulmonary rehabilitation program in preparation for lung resection surgery for non-small cell lung cancer are concerned.

They are contacted by one of the rehabilitation physiotherapists to carry out an inclusion consultation in the respiratory rehabilitation program. During this session, the study is presented to them and their consent to study is collected.

Participation in or refusal of the study does not affect the overall standard of care provided during the program.

Brief summary: In developed countries cancer has become the second leading cause of death after cardiovascular disease. The lung is a particularly exposed organ since broncho-pulmonary cancers rank second in terms of incidence, and the first rank in terms of mortality of all cancers listed in like reported in United States.

Lung resection surgery is currently the recommended curative treatment for the early stages of non-small cell lung cancer (NSCLC). Despite this preferred indication, some patients can not be eligible for surgery because of their cardiovascular or respiratory comorbidities or their impaired functional capacity.

Thus, the evaluation of aerobic capacity through cardiopulmonary exercise testing (CPET) of patients estimated at risk of postoperative complication is now recommended to estimate the level of predictive risk associated. The American Thoracic Society and the European Respiratory Socitety agree on thresholds of \<10 and\> 20 ml/kg/min of maximum oxygen uptake (VO2peak) respectively determining a high or low postoperative risk, between these two thresholds risk is considered moderate.

Aerobic capacity is traditionally expressed in terms of maximum oxygen uptake (VO2max or VO2peak) evaluated during an incremental CPET. In patients with significant respiratory impairment, these tests are often limited by ventilation and sub-maximally on the metabolic or cardiac parameters. However, the analysis of the VO2 kinetic during a constant-intensity test of moderate intensity is also a relevant way of measuring aerobic conditioning. Indeed, the time constant (τ) of phase II of VO2 kinetics (VO2τ) is a marker that closely reflects the adjustment of oxidative metabolism in skeletal muscle. Analysis of the kinetic parameters of the cardio-respiratory response to exercise has been shown to be reproducible and training-sensitive in patients with chronic obstructive pulmonary disease (COPD). The value of VO2τ was also reported to be strongly correlated with markers of severity and prognosis in COPD patients. Previous work has shown that exercise training can improve the speed of the VO2 kinetic response in COPD patients as well as in healthy subjects.

To date, no study to our knowledge has evaluated the kinetics of the cardiorespiratory response during moderate intensity constant-load test in patients with NSCLC. In this context, this work aims to evaluate the applicability of this measure as well as its evolution during a preoperative exercise training program in patients with NSCLC.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years old;
* Beneficiary of a social security scheme;
* Non-Small Cell Lung Cancer or suspicion of bronchial neoplasia;
* Addressed to respiratory rehabilitation in a preoperative setting with a moderate to high risk estimate (VO2peak \< 20 ml/kg/min);
* Intervention date not established when included in the program or ≥ 5 wk.

Exclusion Criteria:

* Patient under guardianship;
* Pregnant or lactating woman;
* Cardiological contraindication to training;
* Neoadjuvant radio-chemotherapy;
* Refusal to carry out a training program in a rehabilitation center;
* Orthopedic, neurological, vascular or neuromuscular pathology limiting training;
* Exacerbation or deterioration of the general condition requiring stopping the preoperative re-training program;
* Modification of the therapeutic project at a multidisciplinary consultation meeting requiring the cessation of rehabilitation or participation in the study.

Primary outcomes:
measure: Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer
timeFrame: before the preoperative training program
measure: Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer
timeFrame: through preoperative training program completion (15 sessions), an average of 1 month
Secondary outcomes:
measure: Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer
timeFrame: before the preoperative training program
measure: Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer
timeFrame: through preoperative training program completion (15 sessions), an average of 1 month
measure: Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer
timeFrame: before the preoperative training program
measure: Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer
timeFrame: through preoperative training program completion (15 sessions), an average of 1 month
measure: Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer
timeFrame: before the preoperative training program
measure: Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer
timeFrame: through preoperative training program completion (15 sessions), an average of 1 month
measure: Peak oxygen uptake (VO2peak) obtained during the incremental cardiopulmonary exercise testing
timeFrame: before the preoperative training program
measure: Peak oxygen uptake (VO2peak) obtained during the incremental cardiopulmonary exercise testing
timeFrame: through preoperative training program completion (15 sessions), an average of 1 month
measure: Maximum heart rate (HRmax) reached during the incremental cardiopulmonary exercise testing
timeFrame: before the preoperative training program
measure: Maximum heart rate (HRmax) reached during the incremental cardiopulmonary exercise testing
timeFrame: through preoperative training program completion (15 sessions), an average of 1 month
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
state: Normandie
Study officials:
References: