Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment rehabilitation
Sponsor Rigshospitalet, Denmark
Start date April 2014
End date June 2017
Trial size 235 participants
Trial identifier NCT02439073, H-3-2012-028

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
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.
rehabilitation exercise intervention
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.
(Active Comparator)
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.
rehabilitation exercise intervention
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.

Primary Outcomes

Measure
A change in maximum oxygen consumption
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)

Secondary Outcomes

Measure
Patient Reported outcomes
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
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
time frame: Baseline, post intervention, follow-up at 26 and 52 weeks after surgery
A change in maximum oxygen consumption
time frame: A change in maximum oxygen consumption from baseline to 52 weeks after operation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.