Perioperative Rehabilitation in Operation for Lung Cancer (PROLUCA)

This study is currently recruiting participants.
Verified July 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Center for Integrated Rehabilitation of Cancer patients, CIRE
Danish Cancer Society
Novo Nordisk A/S
Faculty of Health Sciences, University of Copenhagen
Copenhagen Centre for Cancer and Health, Municipality of Copenhagen
Information provided by (Responsible Party):
Jesper Holst Pedersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01893580
First received: June 20, 2013
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

Background Lung cancer is one of the most frequently occurring cancer diagnoses in both men and women having the highest death rate. Lung cancer is divided into Small-Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC). Surgery is at present the primary treatment for NSCLC. Modern surgical treatment includes both minimal invasive surgery, e.g. Video-Assisted Thoracoscopic surgery (VATS), and open surgery such as thoracotomy.

Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal. Accordingly, side-effects to the treatment of the lung cancer disease are clinically very important and comprise physical and psychological as well as social distress with symptoms such as reduced physical capacity, numbness, pain, tiredness (fatigue), anxiety, and depression. These side-effects are long-lasting or even chronic and may result in a limitation in activity of daily living and reduced quality of life.

Study aim:

The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life. The specific study aim are to compare a home based exercise program (carried out before surgery), combined with exercise initiated as early as two weeks after surgery, with usual care (exercise initiated six weeks after surgery).

Who can participate? Both men and women with an age above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if Danish is not spoken or understood, or if the participants by a doctor are advise not to do strenuous exercise.

What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.

  1. Exercise before surgery is a home-based exercise program is individually designed. The goal of the home-based exercise program, carried out before surgery, is to encourage to perform physical exercise (could be walking, cycling,climbing stairs) for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
  2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group based lessons in health promoting behavior. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered.

The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week. Containing the following elements: Warm-up (five minutes) and cycling exercise (25 minutes) on ergometer bike, individually prepared strength exercise (25 minutes) carried out using five strength machines (whole body). Trained physiotherapists and cancer nurse specialists supervise the training program following the recommended principles. All exercise sessions will at the end include supervised breathing exercises combined with stretching and relaxation techniques (five minutes).

What interventions will be compared? A home-based exercise program (carried out before surgery), combined with exercise initiated as early as two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).

Will all participants receive the same treatment?

By draw it is decided which of the 4 groups the participants will attend to in the study:

  • Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
  • Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
  • Group 3: Rehabilitation initiated as early as two weeks after surgery
  • Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group)

What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.


Condition Intervention
Lung Cancer
Non Small Cell Lung Cancer
Behavioral: Experimental: Preoperative and early postoperative rehabilitation
Behavioral: Experimental: Preoperative and late postoperative rehabilitation
Behavioral: Experimental: Early postoperative rehabilitation alone
Behavioral: Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Rehabilitation in Operation for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Maximum oxygen uptake (VO2peak) [ Time Frame: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. ] [ Designated as safety issue: No ]
    VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©). Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©). Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.).


Secondary Outcome Measures:
  • Six minute walk distance (6MWD) [ Time Frame: baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. ] [ Designated as safety issue: No ]
  • Patient reported outcomes (PROs) [ Time Frame: Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. ] [ Designated as safety issue: No ]
    PROs will include health related quality of life, symptoms and side-effects, anxiety and depression, well-being, distress, lifestyle, sickness absence, work status, and social support.

  • Pulmonary function [ Time Frame: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. ] [ Designated as safety issue: No ]
    forced expiratory volume at one second


Estimated Enrollment: 380
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative and early postoperative rehabilitation
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.
Behavioral: Experimental: Preoperative and early postoperative rehabilitation

Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.

Intervention consists of:

  1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity (~60-80% of maximum heart rate (HRmax)) for at least 30 minutes every day until surgery.
  2. Postoperative rehabilitation: 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.

Experimental: Preoperative and late postoperative rehabilitation
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery.
Behavioral: Experimental: Preoperative and late postoperative rehabilitation

Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:

  1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity (~60-80% of maximum heart rate (HRmax)) for at least 30 minutes every day until surgery.
  2. Postoperative rehabilitation: 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.

Experimental: Early postoperative rehabilitation alone
Exercise in a team initiated two weeks after surgery.
Behavioral: Experimental: Early postoperative rehabilitation alone

Exercise in a team initiated two weeks after surgery, consisting 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.

Usual care
Exercise in a team initiated six weeks after surgery.
Behavioral: Other: Usual care

Exercise in a team initiated six weeks after surgery consisting 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Cardiac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893580

Contacts
Contact: Jesper Holst Pedersen, MD, DrMSci +45 3545 8014 jesper.holst.pedersen@regionh.dk
Contact: Jette Vibe-Petersen, MD +45 2637 3729 jvp@kraeftcenter-kbh.dk

Locations
Denmark
Copenhagen Centre for Cancer and Health Recruiting
Copenhagen, Nørrebro, Denmark, DK-2200
Contact: Jette Vibe-Petersen, MD    +45 2637 3729    jvp@kraeftcenter-kbh.dk   
Contact: Maja Schick Sommer, Master in Health Science    +45 23840661    mss@kraeftcenter-kbh.dk   
Principal Investigator: Maja Schick Sommer, Master in Health Science         
Sponsors and Collaborators
Rigshospitalet, Denmark
Center for Integrated Rehabilitation of Cancer patients, CIRE
Danish Cancer Society
Novo Nordisk A/S
Faculty of Health Sciences, University of Copenhagen
Copenhagen Centre for Cancer and Health, Municipality of Copenhagen
Investigators
Study Chair: Jesper Holst Pedersen, MD, DrMSci Department of Cardiothoracic Surgery RT
Study Director: Jette Vibe-Petersen, MD Copenhagen Centre for Cancer and Health
Principal Investigator: Maja Schick Sommer, Master in Health Science Copenhagen Centre for Cancer and Health
  More Information

No publications provided

Responsible Party: Jesper Holst Pedersen, MD, DrMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01893580     History of Changes
Other Study ID Numbers: PROLUCA, 2007-58-0015
Study First Received: June 20, 2013
Last Updated: July 2, 2013
Health Authority: Denmark: Copenhagen University Hospital, Rigshospitalet.

Keywords provided by Rigshospitalet, Denmark:
Cancer
Rehabilitation
Exercise
Lung cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014