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Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

NCT ID: NCT00869011

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Keywords

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Cancer renal cell carcinoma fatigue exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Exercise

Group Type EXPERIMENTAL

Endurance exercise

Intervention Type OTHER

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

2

No structured exercise program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endurance exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Sports Medicine, Charité Universitätsmedizin Berlin

Locations

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Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fernando C. Dimeo, MD

Role: CONTACT

Phone: +493084452098

Email: [email protected]

Facility Contacts

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Fernando C. Dimeo, MD

Role: primary

Other Identifiers

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SUIR8687

Identifier Type: -

Identifier Source: org_study_id