Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early initiated rehabilitation<br>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. | Behavioral: Rehabilitation<br>* 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.<br>* Other names: exercise intervention;|
| Active Comparator: late initiated rehabilitation<br>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. | Behavioral: Rehabilitation<br>* 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.<br>* Other names: exercise intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported outcomes | EORTC QLQ-C30, EORTC-LC13, FACT-L, SF-36, HADS, The distress thermometer, MSPSS, PAS2 | Baseline, post intervention, follow-up at 26 and 52 weeks after surgery | 
| Six minutes walk distance |  | Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery | 
| Lung capacity | Spirometry | 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 | 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 | A change in maximum oxygen consumption from baseline to 52 weeks after operation |