Lung CancerPROLUCANCT02439073
Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)
A study testing Rehabilitation in people with Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Jun 2017
- 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
- All subjects are assigned for curative lung cancer surgery at Department of Cardiothoracic Surgery RT at Copenhagen University Hospital (Rigshospitalet)
- Performance status 0-2 (WHO)
- Living in the City of Copenhagen or surrounding Municipalities
- Ability to read and understand Danish
- Approval by primary surgeon
Who cannot join
- Presence of metastatic disease or surgical inoperability. Diagnosis of Lung Cancer not verified by histological diagnosis.
- Decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, acute coronary syndrome
- Contraindications to maximal exercise testing as recommended by the American Thoracic Society and exercise testing guidelines for cancer patients
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Centre for Cancer and Health
Copenhagen, Capital Region of Denmark, DK-2200
About this study
Official title: Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation
Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training.
Design/Methods
Read more
One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the following two groups:
- Early postoperative rehabilitation initiated as early as two weeks after surgery
- Postoperative rehabilitation initiated 14 weeks after surgery Intervention The intervention consists of a supervised group exercise program comprising resistance and cardiorespiratory exercise two hours weekly for 12 weeks combined with individual counseling.
The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct measurement) Secondary endpoints include: Six minutes walk distance (6MWD), One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick leave, work status and survival.
Results The results of PROLUCA will identify the optimal timing of postoperative rehabilitation in NSCLC patients with focus on increasing physical capacity and health related quality of life and reducing the side effects from the treatment of the cancer disease.
- Conditions
- Lung Cancer
- Being tested
- Rehabilitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Also called exercise intervention
The postoperative intervention are the same in both intervention groups and consists of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.The postoperative physical exercise consists of an individually prepared supervised strength exercise - and a group-based cardiovascular exercise twice a week (60 minutes/session) on non-consecutive days for 12 weeks, a total of 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| early initiated rehabilitation | Experimental | A supervised 12-week rehabilitation program, initiated two weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. Receives: Behavioral: Rehabilitation |
| late initiated rehabilitation | Active comparator | A supervised 12-week rehabilitation program, initiated 14 weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. Receives: Behavioral: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in maximum oxygen consumption
A change in maximum oxygen consumption from baseline to post interventon, measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer
Measured: A change in maximum oxygen consumption from baseline to post intervention (for group one, the experimental group, it is approximately 14 weeks after the operation and for group two it is approximately 26 weeks after the operation)
Secondary outcomes (5)
Patient Reported outcomes
EORTC QLQ-C30, EORTC-LC13, FACT-L, SF-36, HADS, The distress thermometer, MSPSS, PAS2
Measured: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
Six minutes walk distance
Measured: Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery
Lung capacity
Spirometry
Measured: Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery
Muscle strength chest and leg press
one repetition maximum
Measured: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
A change in maximum oxygen consumption
measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer
Measured: A change in maximum oxygen consumption from baseline to 52 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startApr 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Holst Pedersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper H. Pedersen, MD, MrDSci, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439073
- Sponsor's protocol ID
- H-3-2012-028
- Acronym
- PROLUCA
- Status last verified
- Jun 2016
- First submitted
- 29 Jan 2015
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation
- ClinicalTrials.gov ID
- NCT02439073
- Acronym / sponsor ID
- PROLUCA / H-3-2012-028
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 May 2015 (estimated)
- 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.
Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training.
Design/Methods
One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the following two groups:
- Early postoperative rehabilitation initiated as early as two weeks after surgery
- Postoperative rehabilitation initiated 14 weeks after surgery Intervention The intervention consists of a supervised group exercise program comprising resistance and cardiorespiratory exercise two hours weekly for 12 weeks combined with individual counseling.
The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct measurement) Secondary endpoints include: Six minutes walk distance (6MWD), One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick leave, work status and survival.
Results The results of PROLUCA will identify the optimal timing of postoperative rehabilitation in NSCLC patients with focus on increasing physical capacity and health related quality of life and reducing the side effects from the treatment of the cancer disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early initiated rehabilitation | Experimental | Behavioral: RehabilitationA supervised 12-week rehabilitation program, initiated two weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. |
| late initiated rehabilitation | Active comparator | Behavioral: RehabilitationA supervised 12-week rehabilitation program, initiated 14 weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects are assigned for curative lung cancer surgery at Department of Cardiothoracic Surgery RT at Copenhagen University Hospital (Rigshospitalet)
- Performance status 0-2 (WHO)
- Living in the City of Copenhagen or surrounding Municipalities
- Ability to read and understand Danish
- Approval by primary surgeon
Key exclusion criteria (3 listed)
- Presence of metastatic disease or surgical inoperability. Diagnosis of Lung Cancer not verified by histological diagnosis.
- Decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, acute coronary syndrome
- Contraindications to maximal exercise testing as recommended by the American Thoracic Society and exercise testing guidelines for cancer patients
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 |
|---|---|---|
| RehabilitationAlso: exercise interventionThe postoperative intervention are the same in both intervention groups and consists of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.The postoperative physical exercise consists of an individually prepared supervised strength exercise - and a group-based cardiovascular exercise twice a week (60 minutes/session) on non-consecutive days for 12 weeks, a total of 24 sessions. | Behavioural | early initiated rehabilitation, late initiated rehabilitation |
Primary outcome
A change in maximum oxygen consumption
Time frame: A change in maximum oxygen consumption from baseline to post intervention (for group one, the experimental group, it is approximately 14 weeks after the operation and for group two it is approximately 26 weeks after the operation)
A change in maximum oxygen consumption from baseline to post interventon, measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer
5 secondary outcomes
Patient Reported outcomes
Time frame: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
Six minutes walk distance
Time frame: Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery
Lung capacity
Time frame: Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery
Muscle strength chest and leg press
Time frame: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
A change in maximum oxygen consumption
Time frame: A change in maximum oxygen consumption from baseline to 52 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jesper H. Pedersen, MD, MrDSci study director
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 Rehabilitation in people with Lung Cancer, 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 5 inclusion and 3 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 24 Jun 2016. 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?
A change in maximum oxygen consumption (time frame: A change in maximum oxygen consumption from baseline to post intervention (for group one, the experimental group, it is approximately 14 weeks after the operation and for group two it is approximately 26 weeks after the operation)). 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 24 Jun 2016.