Back to resultsA Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer
Primary Purpose
Prostatic Neoplasms, Neoplasm Metastasis, Palliative Care
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring exercise, exercise therapy, activities of daily living, quality of life
Eligibility Criteria
Inclusion Criteria: diagnosis of prostate cancer receiving docetaxel-based chemotherapy at the CCI age 18 years or over approval of oncologist informed written consent Exclusion Criteria: 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
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
feasibility (recruitment, adherence, safety)
Secondary Outcome Measures
quality of life
functional abilities
Full Information
NCT ID
NCT00271687
First Posted
December 30, 2005
Last Updated
February 24, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00271687
Brief Title
A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer
Official Title
A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Neoplasm Metastasis, Palliative Care
Keywords
exercise, exercise therapy, activities of daily living, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Primary Outcome Measure Information:
Title
feasibility (recruitment, adherence, safety)
Secondary Outcome Measure Information:
Title
quality of life
Title
functional abilities
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of prostate cancer
receiving docetaxel-based chemotherapy at the CCI
age 18 years or over
approval of oncologist
informed written consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Courneya, M.D.
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer
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