NCT01943578

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

August 30, 2013

Last Update Submit

November 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality - Survival time

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

    time from first chemotherapy treatment to death, assessed after 30 months

Secondary Outcomes (3)

  • Hand grip strength

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

  • Self reported exercise behavior

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

  • Six minute walk test

    Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.

Other Outcomes (1)

  • FACT-L

    Before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.

Study Arms (1)

lung cancer patients

Non Small Cell Lung Cancer, Small Cell Lung Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non Small Cell Lung Cancer Stage Small Cell Lung Cancer

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Seppo Langer, Phd.

    University Hospital of Copenhagen, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd student

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 17, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations