Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

Renal Cell Carcinoma Clinical Trial

Official title:

Effects of Physical Activity on the Endothelial and Cardiac Function of Patients With Renal Cell Carcinoma Receiving a Thyrosine Kinase Inhibitor (Sunitinib)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00869011
• Other study ID #: SUIR8687
• Status: Recruiting
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: December 21, 2009
• Start date: December 2009

Study information

• Verified date: December 2009
• Source: Charite University, Berlin, Germany
• Contact: Fernando C. Dimeo, MD
• Phone: +493084452098
• Email: fernando.dimeo[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Endurance exercise
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.

Locations

Country	Name	City	State
Germany	Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue		12 weeks	No
Secondary	VO2max		12 weeks	No
Secondary	Systolic and diastolic blood pressure (24 h)		12 weeks	No
Secondary	Depression score		12 weeks	No