The Effect of Endurance Training in Patients With Prostat... | NCT01584960

Studies
The Effect of Endurance Training in Patients With Prostate Cancer

NCT01584960

Sponsor

Inge Holm

Status

Completed

Last Update Posted

Dec 2, 2013Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Prostate Cancer
Insulin Sensitivity
Body Composition, Beneficial

Interventions

endurance training

Countries

Denmark

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 24, 2012

First Submission Date that Met QC Criteria

Apr 24, 2012

First Posted Date

Apr 25, 2012Estimated

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

Nov 29, 2013

Last Update Posted Date

Dec 2, 2013Estimated

Name	Class
Herlev Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostate cancer, endurance training	Experimental	Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention	Behavioral: endurance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endurance training	Behavioral	2 years of home-based endurance training	Prostate cancer, endurance training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA doubling time		2 years

Secondary Outcomes

Measure	Description	Time Frame
Insulin sensitivity, body composition and inflammation status		0 months, 6 months and 24 months of training

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prostate cancer patients with an increase in PSA following radical prostatectomy

Exclusion Criteria:

severe cardiovascular disease
severe arthritis
severe neuropathy
severe hypertension
therapy with antidiabetic agents
other treatment for prostate cancer than radical prostatectomy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bente K Pedersen	Centre of Inflammation and Metabolism, Rigshospitalet	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre of Inflammation and Metabolism, Rigshospitalet		Copenhagen	Copenhagen	2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D007333	Insulin Resistance
C564221	Glucocorticoid Receptor Deficiency

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000076663	Endurance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided