Clinical trial NCT01893580: Perioperative Rehabilitation in Operation for Lung Cancer
Official title: Perioperative Rehabilitation in Operation for Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Keywords: Cancer
Rehabilitation
Exercise
Lung cancer
NSCLC
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark
name: Danish Cancer Society
name: Novo Nordisk A/S
name: University of Copenhagen
name: Copenhagen Centre for Cancer and Health, Denmark.
First posted: 2013-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Maximum oxygen uptake (VO2peak)
timeFrame: 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.
Secondary outcomes:
measure: Six minute walk distance (6MWD)
timeFrame: 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.
measure: Patient reported outcomes (PROs)
timeFrame: 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.
measure: Pulmonary function
timeFrame: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Centre for Cancer and Health
state: Nørrebro
Study officials:
affiliation: Department of Cardiothoracic Surgery RT
name: Jesper Holst Pedersen, MD, DrMSci
role: STUDY_CHAIR
affiliation: Copenhagen Centre for Cancer and Health
name: Jette Vibe-Petersen, MD
role: STUDY_DIRECTOR
affiliation: Copenhagen Centre for Cancer and Health
name: Maja Schick Sommer, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sommer MS, Trier K, Vibe-Petersen J, Missel M, Christensen M, Larsen KR, Langer SW, Hendriksen C, Clementsen P, Pedersen JH, Langberg H. Perioperative rehabilitation in operation for lung cancer (PROLUCA) - rationale and design. BMC Cancer. 2014 Jun 4;14:404. doi: 10.1186/1471-2407-14-404.