Clinical trial NCT03066271: Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
Official title: PRIME - Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Small Cell Lung Cancer Stage
Chemoradiation
Keywords: Aerobic exercise
Lung Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2017-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum oxygen uptake - VO2peak
timeFrame: Change from baseline at 7 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: Baseline and 7 weeks
measure: Forced Expiratory Volume in one second
timeFrame: Baseline and 7 weeks
measure: Lung Function
timeFrame: Baseline and 7 weeks
measure: Hypoxia in tumor
timeFrame: Baseline and 7 weeks
measure: Stroke volumen
timeFrame: Baseline, selected test samples during training intervention and 7 weeks
measure: Cardiac output
timeFrame: Baseline, selected test samples during training intervention and 7 weeks
measure: Systemic vascular resistance
timeFrame: Baseline, selected test samples during training intervention and 7 weeks
measure: Safety: Sports-injury, Pain, Neuropathies, Nausea/vomiting, Fatigue etc.
timeFrame: Baseline, during intervention and 7 weeks
measure: Respiratory exchange ratio (RER)
timeFrame: Change from baseline at 7 weeks
measure: Rated Perceived Exertion (RPE) Scale
timeFrame: Change from baseline at 7 weeks
Other outcomes:
measure: Overall survival rate
timeFrame: 26 weeks and 52 weeks
measure: Physical Activity
timeFrame: Change from baseline at 7 weeks
measure: Quality of life and wellbeing
timeFrame: Change from baseline at 7 weeks
measure: Anxiety and depression
timeFrame: Change from baseline at 7 weeks
measure: Activity Data
timeFrame: Every day in 24h during the course of radiotherapy treatment
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen
Study officials:
affiliation: Rigshospitalet, Denmark
name: Morten Quist, Post. doc
role: PRINCIPAL_INVESTIGATOR
References: