PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training
ELIFIT
A Prospective, Single Arm Study in Prostate Cancer Patients Managed With Androgen Deprivation Therapy to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training (ELIFIT)
1 other identifier
observational
271
1 country
23
Brief Summary
The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
23 active sites
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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJanuary 24, 2022
January 1, 2022
6 years
July 30, 2015
January 7, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Changes in the patient quality of life (QoL) using the EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient.
Month 0 to Month 36
Changes in the patient quality of life (QoL) using the FACT-P
The FACT-P (Functional Assessment of Cancer Therapy - Prostate) is a questionnaire used to assess the health-related quality of life in men with prostate cancer.
Month 0 to Month 36
Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale
The FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale is a questionnaire that measures an individuals level of fatigue during their usual daily activities over the past week.
Month 0 to Month 36
Secondary Outcomes (7)
Determine compliance of home-based exercises and regular physical activities
3 Years
Determine the impact of exercise and physician support on activity levels
3 Years
Assess the impact of nutritional guidance and exercise with physician support on BMI
3 Years
Mobility of prostate cancer patients measured by TUG Test
3 Years
Determine the safety and tolerability of ADT in the management of prostate cancer
3 Years
- +2 more secondary outcomes
Eligibility Criteria
Patients that are being treated for prostate cancer with urologists in a community or academic/hospital setting.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CMX Researchlead
- Sanoficollaborator
Study Sites (23)
Southern Interior Medical Research Inc.
Kelowna, British Columbia, V1W 4V5, Canada
Silverado Research Inc.
Victoria, British Columbia, V8T 2C1, Canada
Barrie Urology Group
Barrie, Ontario, L4M 7G1, Canada
Euroscope Inc.
Barrie, Ontario, L4M 7G1, Canada
Dr. Gregory Leal
Belleville, Ontario, K8P 3Z9, Canada
Jonathan Giddens Medical Professional Corp.
Brampton, Ontario, L6T 4S5, Canada
Brantford Urology Research
Brantford, Ontario, N3S 6T6, Canada
Kenneth Jansz Medical Professional Corp.
Burlington, Ontario, L7N 3V2, Canada
Michael L. Pianezza Medicine Professional Corp.
Greater Sudbury, Ontario, P3E 4T3, Canada
Northern Urology Centre
Greater Sudbury, Ontario, P3E 4T3, Canada
Stanley Flax Medical Professional Corp.
North York, Ontario, M2J 1V1, Canada
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
The Fe/Male Health Centre
Oakville, Ontario, L6H 3P1, Canada
Kawartha Urology
Peterborough, Ontario, K9H 1T6, Canada
Urology Clinic
Scarborough Village, Ontario, M1S 4V5, Canada
Dr. Jonathan Chan Medical Professional Corp.
Toronto, Ontario, M1V 0E3, Canada
Umesh Jain Medicine Professional Corp.
Toronto, Ontario, M6S 4W4, Canada
Recherches Cliniques Theradev
Granby, Quebec, J2G 8Z9, Canada
UroLaval
Laval, Quebec, H7G 2E6, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Ultra-Med Inc.
Pointe-Claire, Quebec, H9R 4S3, Canada
CHU de Quebec - L'hotel-dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Centre de Recherche en Urologie de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 9H3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Casey, MD
CMX Research
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
August 15, 2019
Study Start
November 1, 2013
Primary Completion
November 1, 2019
Study Completion
July 1, 2020
Last Updated
January 24, 2022
Record last verified: 2022-01