NCT01676480

Brief Summary

The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

January 10, 2012

Last Update Submit

September 3, 2012

Conditions

Prostate Cancer

Keywords

Prostate cancerADTEndurance training

Outcome Measures

Primary Outcomes (1)

  • Changes in body composition and insulin sensitivity in response to training

    Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training

Study Arms (2)

ADT group

EXPERIMENTAL
Behavioral: Endurance training

Control group

EXPERIMENTAL
Behavioral: Endurance training

Interventions

Endurance trainingBEHAVIORAL

12 weeks of endurance training 3 times per week

ADT groupControl group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer patients receiving ADT for at least 3 months
  • Healthy age and BMI matched controls

You may not qualify if:

  • severe cardiovascular disease
  • severe arthritis
  • severe neuropathy
  • severe hypertension
  • therapy with antidiabetic agents
  • VO2max \> 30.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bente K Pedersen

    Centre of Inflammation and Metabolism, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Administrator

Study Record Dates

First Submitted

January 10, 2012

First Posted

August 31, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

DK(1)