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

Cancer of the Prostate Clinical Trial

— ELIFIT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057859
• Other study ID #: CMX-SC-2013-001
• Status: Completed
• Start date: November 2013
• Est. completion date: July 2020

Study information

• Verified date: January 2022
• Source: CMX Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: July 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Barrie Urology Group	Barrie	Ontario
Canada	Euroscope Inc.	Barrie	Ontario
Canada	Dr. Gregory Leal	Belleville	Ontario
Canada	Jonathan Giddens Medical Professional Corp.	Brampton	Ontario
Canada	Brantford Urology Research	Brantford	Ontario
Canada	Kenneth Jansz Medical Professional Corp.	Burlington	Ontario
Canada	Recherches Cliniques Theradev	Granby	Quebec
Canada	Southern Interior Medical Research Inc.	Kelowna	British Columbia
Canada	UroLaval	Laval	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Stanley Flax Medical Professional Corp.	North York	Ontario
Canada	The Fe/Male Health Centre	Oakville	Ontario
Canada	The Fe/Male Health Centres	Oakville	Ontario
Canada	Kawartha Urology	Peterborough	Ontario
Canada	Ultra-Med Inc.	Pointe-Claire	Quebec
Canada	CHU de Quebec - L'hotel-dieu de Quebec	Quebec City	Quebec
Canada	Urology Clinic	Scarborough	Ontario
Canada	Centre de Recherche en Urologie de Lanaudiere	St. Charles Borromee	Quebec
Canada	Michael L. Pianezza Medicine Professional Corp.	Sudbury	Ontario
Canada	Northern Urology Centre	Sudbury	Ontario
Canada	Dr. Jonathan Chan Medical Professional Corp.	Toronto	Ontario
Canada	Umesh Jain Medicine Professional Corp.	Toronto	Ontario
Canada	Silverado Research Inc.	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
CMX Research	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	# 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
Secondary	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