Clinical trial NCT02439073: Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)
Official title: Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: A change in maximum oxygen consumption
timeFrame: 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 outcomes:
measure: Patient Reported outcomes
timeFrame: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
measure: Six minutes walk distance
timeFrame: Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery
measure: Lung capacity
timeFrame: Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery
measure: Muscle strength chest and leg press
timeFrame: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
measure: A change in maximum oxygen consumption
timeFrame: A change in maximum oxygen consumption from baseline to 52 weeks after operation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Centre for Cancer and Health
state: Capital region of Denmark
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jesper H. Pedersen, MD, MrDSci
role: STUDY_DIRECTOR
References: