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)

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

Study Overview

• Status: Completed
• Conditions: Cancer of the Prostate

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 4V5
      • Southern Interior Medical Research Inc.
    • Victoria, British Columbia, Canada, V8T 2C1
      • Silverado Research Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Barrie Urology Group
    • Barrie, Ontario, Canada, L4M 7G1
      • Euroscope Inc.
    • Belleville, Ontario, Canada, K8P 3Z9
      • Dr. Gregory Leal
    • Brampton, Ontario, Canada, L6T 4S5
      • Jonathan Giddens Medical Professional Corp.
    • Brantford, Ontario, Canada, N3S 6T6
      • Brantford Urology Research
    • Burlington, Ontario, Canada, L7N 3V2
      • Kenneth Jansz Medical Professional Corp.
    • North York, Ontario, Canada, M2J 1V1
      • Stanley Flax Medical Professional Corp.
    • Oakville, Ontario, Canada, L6H 3P1
      • The Fe/Male Health Centres
    • Oakville, Ontario, Canada, L6H 3P1
      • The Fe/Male Health Centre
    • Peterborough, Ontario, Canada, K9H 1T6
      • Kawartha Urology
    • Scarborough, Ontario, Canada, M1S 4V5
      • Urology Clinic
    • Sudbury, Ontario, Canada, P3E 4T3
      • Northern Urology Centre
    • Sudbury, Ontario, Canada, P3E 4T3
      • Michael L. Pianezza Medicine Professional Corp.
    • Toronto, Ontario, Canada, M1V 0E3
      • Dr. Jonathan Chan Medical Professional Corp.
    • Toronto, Ontario, Canada, M6S 4W4
      • Umesh Jain Medicine Professional Corp.
  • Quebec
    • Granby, Quebec, Canada, J2G 8Z9
      • Recherches Cliniques Theradev
    • Laval, Quebec, Canada, H7G 2E6
      • UroLaval
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Ultra-Med Inc.
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHU de Quebec - L'Hotel-Dieu de Quebec
    • St. Charles Borromee, Quebec, Canada, J6E 9H3
      • Centre de Recherche en Urologie de Lanaudiere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients that are being treated for prostate cancer with urologists in a community or academic/hospital setting.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine compliance of home-based exercises and regular physical activities	To determine the compliance of home-based exercises and regular physical activities using a weekly activity log.	3 Years
Determine the impact of exercise and physician support on activity levels	To determine the impact of exercise and physician support on activity levels using the weekly activity log, home diary or NIKE+ Fuelband.	3 Years
Assess the impact of nutritional guidance and exercise with physician support on BMI	To determine if BMI (body mass index) scores decrease with nutritional guidance and exercise with physician support.	3 Years
Mobility of prostate cancer patients measured by TUG Test	To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Timed Up and Go Test (TUG)	3 Years
Determine the safety and tolerability of ADT in the management of prostate cancer	Safety and tolerability will be assessed based on the number and type of adverse events collected over the study duration.	3 Years
# of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment	To determine # of patients who discontinued ADT therapy over the course of the study with reasons describing why.	3 Years
Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST)	To assess the impact of nutritional guidance and exercise with physician support on the mobility of prostate cancer patients treated with ADT as measured by the Five Times Sit to Stand Test (FTSST).	3 years

Collaborators and Investigators

• Sponsor: CMX Research
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CMX-SC-2013-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED