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Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00869011
First received: March 23, 2009
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
 Other: Endurance exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Fatigue [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VO2max [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure (24 h) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Depression score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Exercise
 Other: Endurance exercise
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.
No Intervention: 2
No structured exercise program

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869011

Contacts
Contact: Fernando C. Dimeo, MD +493084452098 fernando.dimeo@charite.de

Locations
Germany
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Recruiting
Berlin, Germany, 12200
Contact: Fernando C. Dimeo, MD     +493084452098     fernando.dimeo@charite.de    
Principal Investigator: Fernando C. Dimeo, MD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Pfizer
  More Information

No publications provided

Responsible Party: PD Dr. Fernando C. Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00869011     History of Changes
Other Study ID Numbers: SUIR8687
Study First Received: March 23, 2009
Last Updated: December 21, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Cancer
renal cell carcinoma
fatigue
exercise

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013