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Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: March 23, 2009
Last updated: December 21, 2009
Last verified: December 2009
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
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:

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

Primary Outcome Measures:
  • Fatigue [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • VO2max [ Time Frame: 12 weeks ]
  • Systolic and diastolic blood pressure (24 h) [ Time Frame: 12 weeks ]
  • Depression score [ Time Frame: 12 weeks ]

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
Other: Endurance exercise
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.
No Intervention: 2
No structured exercise program


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00869011

Contact: Fernando C. Dimeo, MD +493084452098

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

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

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on August 16, 2017