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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00869011
Date of registration: 23/03/2009
Primary sponsor: Charite University, Berlin, Germany
Public title: Exercise for Patients With Renal Cell Cancer Receiving Sunitinib
Scientific title: Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)
Date of first enrolment: December 2009
Target sample size: 70
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00869011
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care  
Countries of recruitment
Germany
Contacts
Name:   Fernando C. Dimeo, MD
Address: 
Telephone: +493084452098
Email: fernando.dimeo@charite.de
Affiliation: 
Name:   Fernando C. Dimeo, MD
Address: 
Telephone: +493084452098
Email: fernando.dimeo@charite.de
Affiliation: 
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Renal Cell Carcinoma
Intervention(s)
Other: Endurance exercise
Primary Outcome(s)
Fatigue [Time Frame: 12 weeks]
Secondary Outcome(s)
Depression score [Time Frame: 12 weeks]
Systolic and diastolic blood pressure (24 h) [Time Frame: 12 weeks]
VO2max [Time Frame: 12 weeks]
Secondary ID(s)
SUIR8687
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Pfizer
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