Abstract
BackgroundThe purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise.MethodsUsing a 2x2 factorial design with continuous effect endpoint (Maximal Oxygen Uptake (VO2peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late postoperative rehabilitation (starting six weeks after surgery); (3) early postoperative rehabilitation alone; (4) today’s standard care which is postoperative rehabilitation initiated six weeks after surgery. The preoperative rehabilitation program consists of an individually designed, 30-minute home-based exercise program performed daily. The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling. The primary study endpoint is VO2peak and secondary endpoints include: Six-minute walk distance (6MWD), one-repetition-maximum (1RM), pulmonary function, patient-reported outcomes (PROs) on health-related quality of life (HRQoL), symptoms and side effects of the cancer disease and the treatment of the disease, anxiety, depression, wellbeing, lifestyle, hospitalization time, sick leave, work status, postoperative complications (up to 30 days after surgery) and survival. Endpoints will be assessed at baseline, the day before surgery, pre-intervention, post-intervention, six months after surgery and one year after surgery.DiscussionThe results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery.Trial RegistrationNCT01893580
Highlights
The purpose of the Perioperative Rehabilitation in Operation for LUng CAncer (PROLUCA) study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise
Summary Even though rehabilitation, with focus on exercise, is widely recommended to cancer patients, information concerning timing and dose of exercise rehabilitation is lacking when it comes to patients operated for Non-Small Cell Lung Carcinoma (NSCLC)
To our knowledge no previous studies have been published in which postoperative rehabilitation is initiated as early as two weeks after surgery for NSCLC
Summary
The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise. Postoperative complications are experienced by 25% of the patients with NSCLC [2], and the risk of developing postoperative complications during the first two weeks after surgery has been reported to be dependent on different factors, e.g. preoperative cardiorespiratory capacity, measured as VO2peak [1,5]. The physiological consequences of ageing and inactivity combined with the cancer disease and the treatment of cancer result in a marked reduction in VO2peak and functional capacity [6,7,8]. Other factors such as smoking [9], alcohol consumption [10], nutritional status [11] and comorbidity [12] are predictors of postoperative complications. The late side effects are long-lasting or even chronic and may result in restrictions in activity of daily living and reduced quality of life [5,17,18,19,20,21,22,23]
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