NCT00271687

Brief Summary

This study aims to provide preliminary data on the feasibility and outcomes of a 12 week exercise program on the quality of life of men with hormone refractory prostate cancer receiving docetaxel-based chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

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

First Submitted

Initial submission to the registry

December 30, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

February 25, 2016

Status Verified

March 1, 2012

Enrollment Period

1.7 years

First QC Date

December 30, 2005

Last Update Submit

February 24, 2016

Conditions

Prostatic NeoplasmsNeoplasm MetastasisPalliative Care

Keywords

exerciseexercise therapyactivities of daily livingquality of life

Outcome Measures

Primary Outcomes (1)

  • feasibility (recruitment, adherence, safety)

Secondary Outcomes (2)

  • quality of life

  • functional abilities

Interventions

Exercise trainingBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • diagnosis of prostate cancer
  • receiving docetaxel-based chemotherapy at the CCI
  • age 18 years or over
  • approval of oncologist
  • informed written consent

You may not qualify if:

  • life expectancy less than 6 months
  • Karnofsky performance score less than 70
  • contraindications for exercise (e.g. uncontrolled cardiac, respiratory, hypertensive or psychiatric disorder)
  • unable to understand, read, write and speak English
  • unable or unwilling to attend supervised exercise sessions 3 times weekly
  • unable or unwilling to complete outcome assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm MetastasisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kerry Courneya, M.D.

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 4, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 25, 2016

Record last verified: 2012-03

Locations

CA(1)