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Open Access Study protocol

Perioperative rehabilitation in operation for lung cancer (PROLUCA) – rationale and design

Maja S Sommer1*, Karen Trier1, Jette Vibe-Petersen1, Malene Missel2, Merete Christensen2, Klaus R Larsen3, Seppo W Langer4, Carsten Hendriksen5, Paul Clementsen6, Jesper H Pedersen2 and Henning Langberg7

Author Affiliations

1 Copenhagen Centre for Cancer and Health, Municipality of Copenhagen, Nørre Allé 45, DK-2200 Copenhagen, Denmark

2 Department of Cardiothoracic Surgery RT, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, DK- 2100, Copenhagen, Denmark

3 Pulmonary Department L, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark

4 Department of Oncology, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, DK - 2100 Copenhagen, Denmark

5 Department of Public Health, Section of Social Medicine, Copenhagen University, Øster Farimagsgade 5, postbox 2099, DK-1014 Copenhagen, Denmark

6 Department of Pulmonary Medicine, Copenhagen University Hospital Gentofte, Niels Andersens Vej 65, DK-2900 Hellerup, Denmark

7 CopenRehab, Section of Social Medicine, Department of Public Health and Centre for Healthy Ageing, Faculty of Heath Sciences, University of Copenhagen, Copenhagen, Denmark

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BMC Cancer 2014, 14:404  doi:10.1186/1471-2407-14-404

Published: 4 June 2014

Abstract

Background

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.

Methods

Using 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.

Discussion

The 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 Registration

NCT01893580

Keywords:
Cancer; Rehabilitation; Exercise; Lung cancer; NSCLC