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: 1. Early postoperative rehabilitation initiated as early as two weeks after surgery 2. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
235
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.
Copenhagen Centre for Cancer and Health
Copenhagen, Capital Region of Denmark, Denmark
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
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)
Patient Reported outcomes
EORTC QLQ-C30, EORTC-LC13, FACT-L, SF-36, HADS, The distress thermometer, MSPSS, PAS2
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
Spirometry
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
one repetition maximum
Time frame: 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
Time frame: A change in maximum oxygen consumption from baseline to 52 weeks after operation
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