Value of Physical Capacity Tests in Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943578
• Other study ID #: 2007-58-0015-30-1059
• Status: Completed
• Phase: N/A
• First received: August 30, 2013
• Last updated: November 4, 2014
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
Denmark	University Hospital of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FACT-L	Patient reported outcome	Before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.	No
Primary	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	No
Secondary	Hand grip strength		before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.	No
Secondary	Self reported exercise behavior		before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.	No
Secondary	Six minute walk test		Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.	No

External Links

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