PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training

NCT ID: NCT04057859

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2020-07-31

Brief Summary

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The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).

Detailed Description

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The aim of the current observational study will be to examine the level of activity in the prostate cancer population treated with ADT therapy; specifically, the impact of physical activity levels along with nutritional guidance through physician support. The application of an innovative technology to motivate patients will also be examined through the provision of an accelerometer/pedometer (NIKE+ FuelBand). The physical activity will be monitored by a NIKE+ Fuelband or tracked on an activity log.This study will assess the clinical and patient reported outcomes relevant to the management of their prostate cancer, in conjunction with a program assessing daily physical activities and nutritional guidance on the impact on the patient's quality of life, mobility and weight maintenance.

Conditions

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Cancer of the Prostate

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male patient aged ≥ 18 years old
* Able to read and sign an approved Informed Consent Form (ICF)
* Diagnosed with locally advanced or metastatic prostate cancer
* Patient is treatment naive for ADT or has started ADT (3 or 4 month depot injection) AND has not received more than 1 treatment of 3 or 4 month ADT OR Patient is on intermittent therapy with an ADT agent and will be restarting ADT (3 or 4 month depot injection)
* ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
* Willingness to track weekly physical activities with or without participating in a home based exercise program during the course of this study. The physical activities will be tracked with a weekly activity log or a NIKE+ Fuelband

Exclusion Criteria

* Currently participating in a clinical study or observational study
* Has a survival expectancy of \< 2 years
* Has any other condition that, in the opinion of the treating physician, may affect the patient's health or outcome of the trial
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

CMX Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Casey, MD

Role: STUDY_DIRECTOR

CMX Research

Locations

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Southern Interior Medical Research Inc.

Kelowna, British Columbia, Canada

Site Status

Silverado Research Inc.

Victoria, British Columbia, Canada

Site Status

Barrie Urology Group

Barrie, Ontario, Canada

Site Status

Euroscope Inc.

Barrie, Ontario, Canada

Site Status

Dr. Gregory Leal

Belleville, Ontario, Canada

Site Status

Jonathan Giddens Medical Professional Corp.

Brampton, Ontario, Canada

Site Status

Brantford Urology Research

Brantford, Ontario, Canada

Site Status

Kenneth Jansz Medical Professional Corp.

Burlington, Ontario, Canada

Site Status

Michael L. Pianezza Medicine Professional Corp.

Greater Sudbury, Ontario, Canada

Site Status

Northern Urology Centre

Greater Sudbury, Ontario, Canada

Site Status

Stanley Flax Medical Professional Corp.

North York, Ontario, Canada

Site Status

The Fe/Male Health Centres

Oakville, Ontario, Canada

Site Status

The Fe/Male Health Centre

Oakville, Ontario, Canada

Site Status

Kawartha Urology

Peterborough, Ontario, Canada

Site Status

Urology Clinic

Scarborough Village, Ontario, Canada

Site Status

Dr. Jonathan Chan Medical Professional Corp.

Toronto, Ontario, Canada

Site Status

Umesh Jain Medicine Professional Corp.

Toronto, Ontario, Canada

Site Status

Recherches Cliniques Theradev

Granby, Quebec, Canada

Site Status

UroLaval

Laval, Quebec, Canada

Site Status

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Ultra-Med Inc.

Pointe-Claire, Quebec, Canada

Site Status

CHU de Quebec - L'hotel-dieu de Quebec

Québec, Quebec, Canada

Site Status

Centre de Recherche en Urologie de Lanaudiere

Saint-Charles-Borromée, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CMX-SC-2013-001

Identifier Type: -

Identifier Source: org_study_id

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