Non-Small Cell Lung Cancer StagePRIMENCT03066271
Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
A study testing Exercise + in people with Non-Small Cell Lung Cancer Stage and Chemoradiation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer Stage, Chemoradiation
- What is being tested?
- Exercise +
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Apr 2017to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NSCLC who are treated with concomitant chemo- and radiotherapy.
- Age: > 18 year
- WHO performance status 0-1
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRIME - Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
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)).
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer Stage, Chemoradiation
- Being tested
- Exercise +, Control +
- Keywords
- Aerobic exercise, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise +Other
Usual care
Control +Other
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Exercise + usual care | Experimental | The supervised exercise training is carried out on a ergometer cycle as individual daily (mon-fri) training and each exercise training session consists of 20min.
The training comprised a warm-up phase followed by 3 exercise phases. Warm-up consisted of 5min light stationary cycling, adjusted to 50-60% of the patients peak power output determine at the incremental cycle test (iPPO). The first exercise phase comprised of 5min interval training consisting of 5x30 sec intervals at 80-95% of the patient's iPPO. Between each interval, there is a 30 sec pause. The 2nd exercise phase consisted of 5min continuous cycling at an intensity equaling 80% of the patient's iPPO. The 3rd exercise phase was similar to the first exercise phase. Intensities increased progressively from the first week to the last week (from 50%, 80% and 70% of iPPO according to the three different phases to 60%, 95% and 80 % of iPPO respectively. Receives: Other: Exercise + |
| Control - usual care | Experimental | The patients randomized to the control group received no training but will be wearing the activity tracker during the intervention. Receives: Other: Control + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake - VO2peak
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.
Measured: Change from baseline at 7 weeks
Secondary outcomes (10)
Functional capacity
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.
Measured: Baseline and 7 weeks
Forced Expiratory Volume in one second
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.
Measured: Baseline and 7 weeks
Lung Function
Ventilation (VE), Breath frekvens (BF) and tidal volume (Vt) measured by indirect calorimetry.
Measured: Baseline and 7 weeks
Hypoxia in tumor
The extent of hypoxia in human tumors assessed by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
Measured: Baseline and 7 weeks
Stroke volumen
Stroke volumen will be measured by a ClearSight System
Measured: Baseline, selected test samples during training intervention and 7 weeks
Cardiac output
Cardiac output will be measured by a ClearSight System
Measured: Baseline, selected test samples during training intervention and 7 weeks
Systemic vascular resistance
Systemic vascular resistance (SVR) will be measured by a ClearSight System
Measured: Baseline, selected test samples during training intervention and 7 weeks
Safety: Sports-injury, Pain, Neuropathies, Nausea/vomiting, Fatigue etc.
Serious adverse events and adverse events (e.g.)sports-injury, pain, neuropathies, nausea/vomiting, fatigue, neutropenia, fever, diarrhoea, hospitalisation and infection
Measured: Baseline, during intervention and 7 weeks
Respiratory exchange ratio (RER)
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.
Measured: Change from baseline at 7 weeks
Rated Perceived Exertion (RPE) Scale
In the final seconds of the incremental cycle ergometer test self-perceived exertion perception and dyspnoea will be noted.
Measured: Change from baseline at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start3 Apr 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer StageStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Morten Quist, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Morten Quist, Post. doc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066271
- Sponsor's protocol ID
- JRTE
- Other IDs
- H-16048479
- Acronym
- PRIME
- Status last verified
- Oct 2022
- First submitted
- 8 Feb 2017
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIME - Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03066271
- Acronym / sponsor ID
- PRIME / JRTE
- Conditions
- Non-Small Cell Lung Cancer Stage, Chemoradiation
- Keywords
- Aerobic exercise, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Feb 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + usual care | Experimental | Other: Exercise +The supervised exercise training is carried out on a ergometer cycle as individual daily (mon-fri) training and each exercise training session consists of 20min. The training comprised a warm-up phase followed by 3 exercise phases. Warm-up consisted of 5min light stationary cycling, adjusted to 50-60% of the patients peak power output determine at the incremental cycle test (iPPO). The first exercise phase comprised of 5min interval training consisting of 5x30 sec intervals at 80-95% of the patient's iPPO. Between each interval, there is a 30 sec pause. The 2nd exercise phase consisted of 5min continuous cycling at an intensity equaling 80% of the patient's iPPO. The 3rd exercise phase was similar to the first exercise phase. Intensities increased progressively from the first week to the last week (from 50%, 80% and 70% of iPPO according to the three different phases to 60%, 95% and 80 % of iPPO respectively. |
| Control - usual care | Experimental | Other: Control +The patients randomized to the control group received no training but will be wearing the activity tracker during the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with NSCLC who are treated with concomitant chemo- and radiotherapy.
- Age: > 18 year
- WHO performance status 0-1
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Exercise +Usual care | Other | Exercise + usual care |
| Control +Usual care | Other | Control - usual care |
Primary outcome
Maximum oxygen uptake - VO2peak
Time frame: 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.
10 secondary outcomes
Functional capacity
Time frame: Baseline and 7 weeks
Forced Expiratory Volume in one second
Time frame: Baseline and 7 weeks
Lung Function
Time frame: Baseline and 7 weeks
Hypoxia in tumor
Time frame: Baseline and 7 weeks
Stroke volumen
Time frame: Baseline, selected test samples during training intervention and 7 weeks
Cardiac output
Time frame: Baseline, selected test samples during training intervention and 7 weeks
Systemic vascular resistance
Time frame: Baseline, selected test samples during training intervention and 7 weeks
Safety: Sports-injury, Pain, Neuropathies, Nausea/vomiting, Fatigue etc.
Time frame: Baseline, during intervention and 7 weeks
Respiratory exchange ratio (RER)
Time frame: Change from baseline at 7 weeks
Rated Perceived Exertion (RPE) Scale
Time frame: Change from baseline at 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Morten Quist, Post. doc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + in people with Non-Small Cell Lung Cancer Stage and Chemoradiation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 8 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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
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?
Maximum oxygen uptake - VO2peak (time frame: Change from baseline at 7 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 28 Mar 2023.