Perioperative Rehabilitation in Operation for Lung Cancer (PROLUCA)

Rigshospitalet

Status: Terminated

Conditions: Lung Cancer; Non Small Cell Lung Cancer

Treatments: Behavioral: Experimental: 2. Experimental; Behavioral: Experimental: 1. Experimental; Behavioral: Other: 4. Usual care; Behavioral: Experimental: 3. Experimental

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01893580

2007-58-0015

PROLUCA

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

1. Experimental

Experimental group

Description:

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

Treatment:

Behavioral: Experimental: 1. Experimental

2. Experimental

Experimental group

Description:

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

Treatment:

Behavioral: Experimental: 2. Experimental

3. Experimental

Experimental group

Description:

Exercise in a team initiated two weeks after surgery.

Treatment:

Behavioral: Experimental: 3. Experimental

4. Usual care

Other group

Description:

Exercise in a team initiated six weeks after surgery.

Treatment:

Behavioral: Other: 4. Usual care