A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271687
• Other study ID #: SP-14-0049 / 22262
• Status: Completed
• Phase: Phase 2
• First received: December 30, 2005
• Last updated: February 24, 2016
• Start date: February 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms
• Palliative Care
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise training

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility (recruitment, adherence, safety)
Secondary	quality of life
Secondary	functional abilities