NCT01893580

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.

  • 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started May 2012

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

June 20, 2013

Last Update Submit

May 5, 2015

Conditions

Lung CancerNon Small Cell Lung Cancer

Keywords

CancerRehabilitationExerciseLung cancerNSCLC

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake (VO2peak)

    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.).

    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 (3)

  • Six minute walk distance (6MWD)

    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.

  • Patient reported outcomes (PROs)

    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.

  • Pulmonary function

    Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.

Study Arms (4)

1. Experimental

EXPERIMENTAL

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

Behavioral: Experimental: 1. Experimental

2. Experimental

EXPERIMENTAL

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

Behavioral: Experimental: 2. Experimental

3. Experimental

EXPERIMENTAL

Exercise in a team initiated two weeks after surgery.

Behavioral: Experimental: 3. Experimental

4. Usual care

OTHER

Exercise in a team initiated six weeks after surgery.

Behavioral: Other: 4. Usual care

Interventions

Experimental: 1. ExperimentalBEHAVIORAL

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.

Also known as: Preoperative and early postoperative rehabilitation
1. Experimental
Experimental: 2. ExperimentalBEHAVIORAL

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.

Also known as: Preoperative and late postoperative rehabilitation
2. Experimental
Experimental: 3. ExperimentalBEHAVIORAL

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.

Also known as: Early postoperative rehabilitation alone
3. Experimental
Other: 4. Usual careBEHAVIORAL

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.

Also known as: Usual care
4. Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Performance status 0-2 (WHO)
  • Living in the City of Copenhagen or surrounding Municipalities
  • Ability to read and understand Danish
  • Approval by primary surgeon

You may not qualify if:

  • Presence of metastatic disease or surgical inoperability
  • Diagnosis of Lung Cancer not verified by histological diagnosis
  • Cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Centre for Cancer and Health

Copenhagen, Nørrebro, DK-2200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24898680DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsBehavior

Study Officials

  • Jesper Holst Pedersen, MD, DrMSci

    Department of Cardiothoracic Surgery RT

    STUDY CHAIR

  • Jette Vibe-Petersen, MD

    Copenhagen Centre for Cancer and Health

    STUDY DIRECTOR

  • Maja Schick Sommer, MHS

    Copenhagen Centre for Cancer and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DrMSci

Study Record Dates

First Submitted

June 20, 2013

First Posted

July 9, 2013

Study Start

May 1, 2012

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

DK(1)