Cancer of the Prostate Clinical Trial
— ELIFITOfficial 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)
NCT number | NCT04057859 |
Other study ID # | CMX-SC-2013-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2013 |
Est. completion date | July 2020 |
Verified date | January 2022 |
Source | CMX Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CMX Research | Sanofi |
Canada,
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 |
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