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Value of Physical Capacity Tests in Lung Cancer

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01943578
Collaborator
(none)
80
Enrollment
1
Location
9
Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Cohort Study of the Value of the Six Minute Walk Test and Handgrip Strength in Lung Cancer Patients Undergoing Chemotherapy
    Study Start Date :
    Sep 1, 2013
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    lung cancer patients

    Non Small Cell Lung Cancer, Small Cell Lung Cancer

    Outcome Measures

    Primary Outcome Measures

    1. Mortality - Survival time [time from first chemotherapy treatment to death, assessed after 30 months]

      Prognostic value of the six minute walk and handgrip strength on mortality

    Secondary Outcome Measures

    1. Hand grip strength [before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.]

    2. Self reported exercise behavior [before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.]

    3. Six minute walk test [Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.]

    Other Outcome Measures

    1. FACT-L [Before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.]

      Patient reported outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Copenhagen Copenhagen Denmark 2200

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Morten Quist, phd student, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT01943578
    Other Study ID Numbers:
    • 2007-58-0015-30-1059
    First Posted:
    Sep 17, 2013
    Last Update Posted:
    Nov 5, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Nov 5, 2014