Exercise for Patients With Renal Cell Cancer Receiving Su... | NCT00869011

Studies
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

NCT00869011

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Dec 23, 2009Estimated

Enrollment

70Estimated

Phase

Phase 3

Conditions

Renal Cell Carcinoma

Interventions

Endurance exercise

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Not provided

First Submitted Date

Mar 23, 2009

First Submission Date that Met QC Criteria

Mar 24, 2009

First Posted Date

Mar 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Exercise	Other: Endurance exercise
2	No Intervention	No structured exercise program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance exercise	Other	Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
VO2max		12 weeks
Systolic and diastolic blood pressure (24 h)		12 weeks
Depression score

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fernando C. Dimeo, MD	Contact	+493084452098		fernando.dimeo@charite.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30	Recruiting	Berlin	State of Berlin	12200	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell
D009369	Neoplasms
D005221	Fatigue
D009043	Motor Activity

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided