Lung CancerPROLUCANCT01893580
Perioperative Rehabilitation in Operation for Lung Cancer
A study testing Experimental: 1. Experimental, Experimental: 2. Experimental and Experimental: 3. Experimental in people with Lung Cancer and Non Small Cell Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Experimental: 1. Experimental, Experimental: 2. Experimental and Experimental: 3. Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Jan 2015
- 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
- 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
- Cardiac disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Centre for Cancer and Health
Copenhagen, Nørrebro, DK-2200
About this study
Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.
Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.
Read more
Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.
What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.
- Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
- The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.
What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).
Will all participants receive the same treatment?
By draw it is decided which of the 4 groups the participants will attend to in the study:
- Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
- Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
- Group 3: Rehabilitation initiated as early as two weeks after surgery
- Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Being tested
- Experimental: 1. Experimental, Experimental: 2. Experimental, Experimental: 3. Experimental, Other: 4. Usual care
- Keywords
- Cancer, Rehabilitation, Exercise, Lung cancer, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: 1. ExperimentalBehavioural
Also called Preoperative and early postoperative rehabilitation
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:
- Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
- Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
Experimental: 2. ExperimentalBehavioural
Also called Preoperative and late postoperative rehabilitation
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:
- Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
- Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
Experimental: 3. ExperimentalBehavioural
Also called Early postoperative rehabilitation alone
Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:
Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
Other: 4. Usual careBehavioural
Also called Usual care
Exercise in a team initiated six weeks after surgery consisting 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
| Study group | Role | What they receive |
|---|---|---|
| 1. Experimental | Experimental | Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Receives: Behavioral: Experimental: 1. Experimental |
| 2. Experimental | Experimental | Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Receives: Behavioral: Experimental: 2. Experimental |
| 3. Experimental | Experimental | Exercise in a team initiated two weeks after surgery. Receives: Behavioral: Experimental: 3. Experimental |
| 4. Usual care | Other | Exercise in a team initiated six weeks after surgery. Receives: Behavioral: Other: 4. Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen uptake (VO2peak)
VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©). Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©). Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.).
Measured: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Secondary outcomes (3)
Six minute walk distance (6MWD)
Measured: baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Patient reported outcomes (PROs)
PROs will include health related quality of life, symptoms and side-effects, anxiety and depression, well-being, distress, lifestyle, sickness absence, work status, and social support.
Measured: Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Pulmonary function
forced expiratory volume at one second
Measured: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2014
- Study completionJan 2015
Why it stopped: Due to low recruiment rate, the study design is chanced to a feasibility study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark, Danish Cancer Society, Novo Nordisk A/S, University of Copenhagen, Copenhagen Centre for Cancer and Health, Denmark.
- Responsible party
- Principal investigator, Jesper Holst Pedersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper Holst Pedersen, MD, DrMSci, Study chair, Department of Cardiothoracic Surgery RTJette Vibe-Petersen, MD, Study director, Copenhagen Centre for Cancer and HealthMaja Schick Sommer, MHS, Principal investigator, Copenhagen Centre for Cancer and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893580
- Sponsor's protocol ID
- PROLUCA
- Other IDs
- 2007-58-0015
- Acronym
- PROLUCA
- Status last verified
- May 2015
- First submitted
- 20 Jun 2013
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sommer MS, Trier K, Vibe-Petersen J, Missel M, Christensen M, Larsen KR, Langer SW, Hendriksen C, Clementsen P, Pedersen JH, Langberg H. Perioperative rehabilitation in operation for lung cancer (PROLUCA) - rationale and design. BMC Cancer. 2014 Jun 4;14:404. doi: 10.1186/1471-2407-14-404.
PubMed 24898680
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Rehabilitation in Operation for Lung Cancer
- ClinicalTrials.gov ID
- NCT01893580
- Acronym / sponsor ID
- PROLUCA / PROLUCA
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Keywords
- Cancer, Rehabilitation, Exercise, Lung cancer, NSCLC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruiment rate, the study design is chanced to a feasibility study
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark, Danish Cancer Society, Novo Nordisk A/S, University of Copenhagen, Copenhagen Centre for Cancer and Health, Denmark.
- Study start
- May 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jul 2013 (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.
Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.
Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.
Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.
What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.
- Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
- The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.
What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).
Will all participants receive the same treatment?
By draw it is decided which of the 4 groups the participants will attend to in the study:
- Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
- Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
- Group 3: Rehabilitation initiated as early as two weeks after surgery
- Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Experimental | Experimental | Behavioral: Experimental: 1. ExperimentalHome-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. |
| 2. Experimental | Experimental | Behavioral: Experimental: 2. ExperimentalHome-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. |
| 3. Experimental | Experimental | Behavioral: Experimental: 3. ExperimentalExercise in a team initiated two weeks after surgery. |
| 4. Usual care | Other | Behavioral: Other: 4. Usual careExercise in a team initiated six weeks after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Cardiac disease
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 |
|---|---|---|
| Experimental: 1. ExperimentalAlso: Preoperative and early postoperative rehabilitationHome-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of: 1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery. 2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM. | Behavioural | 1. Experimental |
| Experimental: 2. ExperimentalAlso: Preoperative and late postoperative rehabilitationHome-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of: 1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery. 2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM. | Behavioural | 2. Experimental |
| Experimental: 3. ExperimentalAlso: Early postoperative rehabilitation aloneEarly postoperative exercise in a team initiated two weeks after surgery. Intervention consists of: Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM. | Behavioural | 3. Experimental |
| Other: 4. Usual careAlso: Usual careExercise in a team initiated six weeks after surgery consisting 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM. | Behavioural | 4. Usual care |
Primary outcome
Maximum oxygen uptake (VO2peak)
Time frame: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©). Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©). Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.).
3 secondary outcomes
Six minute walk distance (6MWD)
Time frame: baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Patient reported outcomes (PROs)
Time frame: Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Pulmonary function
Time frame: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Results and safety
The study was stopped early (reason given: Due to low recruiment rate, the study design is chanced to a feasibility study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Derived from this study: PubMed 24898680Sommer MS, Trier K, Vibe-Petersen J, Missel M, Christensen M, Larsen KR, Langer SW, Hendriksen C, Clementsen P, Pedersen JH, Langberg H. Perioperative rehabilitation in operation for lung cancer (PROLUCA) - rationale and design. BMC Cancer. 2014 Jun 4;14:404. doi: 10.1186/1471-2407-14-404.
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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 Holst Pedersen, MD, DrMSci study chair
Department of Cardiothoracic Surgery RT
Jette Vibe-Petersen, MD study director
Copenhagen Centre for Cancer and Health
Maja Schick Sommer, MHS principal investigator
Copenhagen Centre for Cancer and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: 1. Experimental, Experimental: 2. Experimental and Experimental: 3. Experimental in people with Lung Cancer and Non Small Cell 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 4 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: stopped early, as of the sponsor's last update on 7 May 2015. 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?
The study was stopped early (reason given: Due to low recruiment rate, the study design is chanced to a feasibility 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: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893580, which also lists 1 linked publication.
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 7 May 2015.