Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)

Rigshospitalet

Status: Unknown

Conditions: Lung Cancer

Treatments: Behavioral: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02439073

H-3-2012-028

Details and patient eligibility

About

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.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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235 participants in 2 patient groups

early initiated rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Rehabilitation

late initiated rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Rehabilitation