Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)

Lung Cancer Clinical Trial

— PROLUCA  

Official title:

Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA) - A Randomized Clinical Trial With Blinded Effect Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02439073
• Other study ID #: H-3-2012-028
• Status: Active, not recruiting
• Phase: N/A
• First received: January 29, 2015
• Last updated: June 23, 2016
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 235
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Rehabilitation
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.

Locations

Country	Name	City	State
Denmark	Copenhagen Centre for Cancer and Health	Copenhagen	Capital region of Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change in maximum oxygen consumption	A change in maximum oxygen consumption from baseline to post interventon, measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer	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)	No
Secondary	Patient Reported outcomes	EORTC QLQ-C30, EORTC-LC13, FACT-L, SF-36, HADS, The distress thermometer, MSPSS, PAS2	Baseline, post intervention, follow-up at 26 and 52 weeks after surgery	No
Secondary	Six minutes walk distance		Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery	No
Secondary	Lung capacity	Spirometry	Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery	No
Secondary	Muscle strength chest and leg press	one repetition maximum	Baseline, post intervention, follow-up at 26 and 52 weeks after surgery	No
Secondary	A change in maximum oxygen consumption	measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer	A change in maximum oxygen consumption from baseline to 52 weeks after operation	No