Clinical trial NCT04057859: PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Prostate
Lead sponsor: CMX Research
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2019-08-15
Enrollment: 271
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are being treated for prostate cancer with urologists in a community or academic/hospital setting.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the patient quality of life (QoL) using the EORTC QLQ-C30
timeFrame: Month 0 to Month 36
measure: Changes in the patient quality of life (QoL) using the FACT-P
timeFrame: Month 0 to Month 36
measure: Changes in the patient quality of life (QoL) using the FACIT Fatigue Scale
timeFrame: Month 0 to Month 36
Secondary outcomes:
measure: Determine compliance of home-based exercises and regular physical activities
timeFrame: 3 Years
measure: Determine the impact of exercise and physician support on activity levels
timeFrame: 3 Years
measure: Assess the impact of nutritional guidance and exercise with physician support on BMI
timeFrame: 3 Years
measure: Mobility of prostate cancer patients measured by TUG Test
timeFrame: 3 Years
measure: Determine the safety and tolerability of ADT in the management of prostate cancer
timeFrame: 3 Years
measure: # of patients who discontinued prescribed treatment or intermittent usage of prescribed treatment
timeFrame: 3 Years
measure: Mobility of prostate cancer patients measured by Five Times Sit to Stand Test (FTSST)
timeFrame: 3 years
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Silverado Research Inc.
state: British Columbia
city: Barrie
country: Canada
facility: Barrie Urology Group
state: Ontario
city: Barrie
country: Canada
facility: Euroscope Inc.
state: Ontario
city: Belleville
country: Canada
facility: Dr. Gregory Leal
state: Ontario
city: Brampton
country: Canada
facility: Jonathan Giddens Medical Professional Corp.
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Burlington
country: Canada
facility: Kenneth Jansz Medical Professional Corp.
state: Ontario
city: North York
country: Canada
facility: Stanley Flax Medical Professional Corp.
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centres
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centre
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Urology
state: Ontario
city: Scarborough
country: Canada
facility: Urology Clinic
state: Ontario
city: Sudbury
country: Canada
facility: Michael L. Pianezza Medicine Professional Corp.
state: Ontario
city: Sudbury
country: Canada
facility: Northern Urology Centre
state: Ontario
city: Toronto
country: Canada
facility: Dr. Jonathan Chan Medical Professional Corp.
state: Ontario
city: Toronto
country: Canada
facility: Umesh Jain Medicine Professional Corp.
state: Ontario
city: Granby
country: Canada
facility: Recherches Cliniques Theradev
state: Quebec
city: Laval
country: Canada
facility: UroLaval
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Pointe-Claire
country: Canada
facility: Ultra-Med Inc.
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec - L'hotel-dieu de Quebec
state: Quebec
city: St. Charles Borromee
country: Canada
facility: Centre de Recherche en Urologie de Lanaudiere
state: Quebec
Study officials:
affiliation: CMX Research
name: Richard Casey, MD
role: STUDY_DIRECTOR
References: