Chemoradiation, Non-Small Cell Lung Cancer Stage
Conditions
Keywords
Aerobic exercise, Lung Cancer
Brief summary
The aim of this study is to evaluate the feasibility and the effect of daily, individual, supervised and structured exercise training before radiotherapy in patients diagnosed with Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The hypotheses are that patients who undergo daily exercise training will increase VO2peak, functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired volume in one second (FEV1)).
Detailed description
Pre intervention screening: Each patient was screened by a clinical nurse specialist prior to participating in the study. Before baseline and post test the patient was screened by a research physiotherapist and/or human physiology students. If one of the following criteria were met, the patient was prohibited from being tested on that day: diastolic blood pressure \<45 or \>95, heart rate (HR) at rest \>115/min, temperature \> 38 0C, respiratory rate at rest \>30/min, infection requiring treatment, fresh bleeding, total leucocyte count \<1.0 109/L or platelets \<50 109/L. Control - Usual care: The patients randomized to the control group received no training but conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires) just as the intervention group. Furthermore, patients in control were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment. Intervention - The patients randomized to the intervention group received daily training and conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires). Furthermore, patients were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment. The supervised daily training was carried out individually and each session had a duration of 20 minutes before patients individual prescribed radiotherapy. Training was conducted at National Hospital of Denmark: Department of Radiation Oncology , section 3981, entry 39. supervised by a research physiotherapist and/or human physiology students. Statistical analysis sample size: According to the sample size the calculation is performed on the basis of alteration in VO2peak from the study EXHALE (55 patients who completed a 6 weeks training period). The calculation is based on an increase of 200 ml/min in VO2peak for patients in the intervention group (SD = 2,48) and it is assumed that the patients in the control group will have a reduction of 100 ml/min (SD = 2,48). Assumptions for calculation of patient numbers are as follows: Type 1 error 0.05, type 2 error 0.20, SD 2.48. This leads to a total number of 24 patients (12 in each arm). A drop-out rate of 40% is included. Therefore another 16 patients is added, which gives a sample size of 40 patients (20 in each arm). Data entry is carried out in the Open Clinica and data analyses will be performed using the computer programs R-Studio/R and SPSS. Data from questionnaires will be analyzed by SPSS. All other data will be analyzed by R. Differences between groups will be analyzed by an unparried t-test whereas differences within groups will be analyzed by a parried t-test. All categorical data are analyzed using the Pearson χ2 tests. Other data (e.g., from questionnaires) are analyzed using logistic regression and chi square or Mantel Haenzel test. Significance level is set at 0.05.
Interventions
OTHERExercise +
Usual care
OTHERControl +
Usual care
Sponsors
University of Copenhagen
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with NSCLC who are treated with concomitant chemo- and radiotherapy. * Age: \> 18 year * WHO performance status 0-1
Exclusion criteria
* Patients with any symptoms or circumstances that advise against physical activity. * Symptomatic heart disease e.g. arrhythmia or myocardial infarction within the last three months. * Congestive heart failure * Patients who do not read and speak Danish. * Brain or bone metastases; * Prolonged bone marrow suppression * Anti-coagulant treatment * Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum oxygen uptake - VO2peak | Change from baseline at 7 weeks | The primary outcome will be VO2peak, assessed with an aerobic capacity (VO2peak) incremental cycle ergometer test performed on a Monark ergometer 839E cycle. At baseline, human physiology students will carry out the incremental cycle test. A physiotherapist who is blinded to the groups wherein the patients are allocated will carry out the posttest. The test consist of a warm-up phase at 10-50 w. After warm-up the load increases by 5-10 w every 60 sec until exhaustion or a possible symptom limitation (e.g. dizziness, sudden pain, vomiting sensation). To analyze the expired gases patients are going to wear a Hans Rudolf Mask during the test. Expired gases will be analyzed continuously by a metabolic breath-by-breath analysis and calculated as an average over 15 sec using the Oxycon Pro. Jaeger measurement system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia in tumor | Baseline and 7 weeks | The extent of hypoxia in human tumors assessed by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). |
| Cardiac output | Baseline, selected test samples during training intervention and 7 weeks | Cardiac output will be measured by a ClearSight System |
| Systemic vascular resistance | Baseline, selected test samples during training intervention and 7 weeks | Systemic vascular resistance (SVR) will be measured by a ClearSight System |
| Safety: Sports-injury, Pain, Neuropathies, Nausea/vomiting, Fatigue etc. | Baseline, during intervention and 7 weeks | Serious adverse events and adverse events (e.g.)sports-injury, pain, neuropathies, nausea/vomiting, fatigue, neutropenia, fever, diarrhoea, hospitalisation and infection |
| Respiratory exchange ratio (RER) | Change from baseline at 7 weeks | To analyze the expired gases patients are going to wear a Hans Rudolf Mask during a incremental cycle ergometer test. Expired gases will be analyzed continuously by a metabolic breath-by-breath analysis and calculated as an average over 15 seconds using the Oxycon Pro. Jaeger measurement system. |
| Rated Perceived Exertion (RPE) Scale | Change from baseline at 7 weeks | In the final seconds of the incremental cycle ergometer test self-perceived exertion perception and dyspnoea will be noted. |
| Functional capacity | Baseline and 7 weeks | Functional capacity is measured by a 6 MWD test. The test is carried out over a pre-measured distance of 20 meters, in compliance with the American Thoracic Society (ATS) statement. After the test the patients will rate the breathing on Borg Scale for dyspnea. |
| Forced Expiratory Volume in one second | Baseline and 7 weeks | Forced Expiratory Volume in 1 second (FEV1) is measured using a standard spirometry in a standing position with the use of the Oxycon Pro, Jaeger measurement system. |
| Lung Function | Baseline and 7 weeks | Ventilation (VE), Breath frekvens (BF) and tidal volume (Vt) measured by indirect calorimetry. |
| Stroke volumen | Baseline, selected test samples during training intervention and 7 weeks | Stroke volumen will be measured by a ClearSight System |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and wellbeing | Change from baseline at 7 weeks | Quality of life and wellbeing - Functional Assessment of Cancer Therapy - Lung (FACT-L). |
| Anxiety and depression | Change from baseline at 7 weeks | Anxiety and depression - Hospital Anxiety and Depression Scale (HAD) |
| Activity Data | Every day in 24h during the course of radiotherapy treatment | Steps, distance and intensity minutes measured by Garmin vivo-smart HR® activity tracker. |
| Physical Activity | Change from baseline at 7 weeks | Physical Activity - International Physical Activity Questionnaire Long (IPAQ-L). |
| Overall survival rate | 26 weeks and 52 weeks | Overall survival be measured from inclusion until death or 26 weeks or 52 weeks |
Countries
Denmark
Outcome results
None listed