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Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

Primary Purpose

Renal Cell Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Endurance exercise
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Cell Carcinoma focused on measuring Cancer, renal cell carcinoma, fatigue, exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Exercise

No structured exercise program

Outcomes

Primary Outcome Measures

Fatigue

Secondary Outcome Measures

VO2max
Systolic and diastolic blood pressure (24 h)
Depression score

Full Information

First Posted
March 23, 2009
Last Updated
December 21, 2009
Sponsor
Charite University, Berlin, Germany
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00869011
Brief Title
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Cancer, renal cell carcinoma, fatigue, exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Exercise
Arm Title
2
Arm Type
No Intervention
Arm Description
No structured exercise program
Intervention Type
Other
Intervention Name(s)
Endurance exercise
Intervention Description
Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.
Primary Outcome Measure Information:
Title
Fatigue
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
VO2max
Time Frame
12 weeks
Title
Systolic and diastolic blood pressure (24 h)
Time Frame
12 weeks
Title
Depression score
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando C. Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
Facility Information:
Facility Name
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando C. Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
First Name & Middle Initial & Last Name & Degree
Fernando C. Dimeo, MD

12. IPD Sharing Statement

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Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

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