Value of Physical Capacity Tests in Lung Cancer

November 4, 2014 updated by: Morten Quist, Rigshospitalet, Denmark

Prospective Observational Cohort Study of the Value of the Six Minute Walk Test and Handgrip Strength in Lung Cancer Patients Undergoing Chemotherapy

The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity.

Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University Hospital of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non Small Cell Lung Cancer Stage Small Cell Lung Cancer

Description

Inclusion Criteria:

  • Non small cell lung cancer stage I-IV
  • Small cell lung cancer
  • Patients >18 years
  • WHO performance status 0-2
  • undergoing chemotherapy

Exclusion Criteria:

  • unstable angina during the previous month
  • myocardial infarction diagnosed within the last month
  • not approval for physical activity by primary oncologist
  • inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
lung cancer patients
Non Small Cell Lung Cancer, Small Cell Lung Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality - Survival time
Time Frame: time from first chemotherapy treatment to death, assessed after 30 months
Prognostic value of the six minute walk and handgrip strength on mortality
time from first chemotherapy treatment to death, assessed after 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hand grip strength
Time Frame: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Self reported exercise behavior
Time Frame: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Six minute walk test
Time Frame: Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.
Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACT-L
Time Frame: Before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Patient reported outcome
Before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Seppo Langer, Phd., University Hospital of Copenhagen, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-58-0015-30-1059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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