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Trial record 1 of 1 for:    NCT00869011
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Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

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ClinicalTrials.gov Identifier: NCT00869011
Recruitment Status : Unknown
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : March 25, 2009
Last Update Posted : December 23, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE March 23, 2009
First Posted Date  ICMJE March 25, 2009
Last Update Posted Date December 23, 2009
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2009)
Fatigue [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
Fatigue [ Time Frame: At recruitment and after 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2009)
  • VO2max [ Time Frame: 12 weeks ]
  • Systolic and diastolic blood pressure (24 h) [ Time Frame: 12 weeks ]
  • Depression score [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
  • VO2max [ Time Frame: At recruitment and after 12 weeks ]
  • Systolic and diastolic blood pressure (24 h) [ Time Frame: At recruitment and after 12 weeks ]
  • Depression score [ Time Frame: At recruitment and after 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise for Patients With Renal Cell Cancer Receiving Sunitinib
Official Title  ICMJE Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)
Brief Summary In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Other: Endurance exercise
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.
Study Arms  ICMJE
  • Experimental: 1
    Exercise
    Intervention: Other: Endurance exercise
  • No Intervention: 2
    No structured exercise program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 24, 2009)
70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 75 years
  • Understanding of written German
  • Treatment with Sunitinib
  • Ability to walk

Exclusion Criteria:

  • Cardiovascular, pulmonary or osteoarticular disease which can be aggravated by exercise
  • BMI < 18 or > 30
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00869011
Other Study ID Numbers  ICMJE SUIR8687
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PD Dr. Fernando C. Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP