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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

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Other: Endurance exercise Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : December 2009
Estimated Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sunitinib

Arm Intervention/treatment
Experimental: 1
Exercise
Other: Endurance exercise
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.

No Intervention: 2
No structured exercise program



Primary Outcome Measures :
  1. Fatigue [ Time Frame: 12 weeks ]

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors