Perioperative Rehabilitation in Operation for Lung Cancer (PROLUCA)

This study has been terminated.
(Due to low recruiment rate, the study design is chanced to a feasibility study)
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: October 8, 2014
Last verified: October 2014
  Purpose

Background: 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.

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.

Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised 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 and must be performed 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 and three individual counseling sessions. 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.

What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated 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: 1. Experimental
Behavioral: Experimental: 2. Experimental
Behavioral: Experimental: 3. Experimental
Behavioral: Other: 4. 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


Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.
Behavioral: Experimental: 1. Experimental

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 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 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 and 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.
Other Name: Preoperative and early postoperative rehabilitation
Experimental: 2. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery.
Behavioral: Experimental: 2. Experimental

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 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 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 and 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.
Other Name: Preoperative and late postoperative rehabilitation
Experimental: 3. Experimental
Exercise in a team initiated two weeks after surgery.
Behavioral: Experimental: 3. Experimental

Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and 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 and 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.

Other Name: Early postoperative rehabilitation alone
4. Usual care
Exercise in a team initiated six weeks after surgery.
Behavioral: Other: 4. 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.

Other Name: Usual care

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893580

Locations
Denmark
Copenhagen Centre for Cancer and Health
Copenhagen, Nørrebro, Denmark, DK-2200
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: October 8, 2014
Health Authority: Denmark: Copenhagen University Hospital, Rigshospitalet.

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

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

ClinicalTrials.gov processed this record on October 19, 2014