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Cancer of the ProstateELIFITNCT04057859

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

An observational study of Cancer of the Prostate, run by CMX Research at 23 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer of the Prostate
How many people
271 participants
Where
23 sitesCanada
Study dates
Nov 2013to Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Canada23 sites

  • Barrie Urology Group

    Barrie, Ontario, L4M 7G1

  • Euroscope Inc.

    Barrie, Ontario, L4M 7G1

  • Dr. Gregory Leal

    Belleville, Ontario, K8P 3Z9

  • Jonathan Giddens Medical Professional Corp.

    Brampton, Ontario, L6T 4S5

  • Brantford Urology Research

    Brantford, Ontario, N3S 6T6

  • Kenneth Jansz Medical Professional Corp.

    Burlington, Ontario, L7N 3V2

  • Recherches Cliniques Theradev

    Granby, Quebec, J2G 8Z9

  • Michael L. Pianezza Medicine Professional Corp.

    Greater Sudbury, Ontario, P3E 4T3

  • Northern Urology Centre

    Greater Sudbury, Ontario, P3E 4T3

  • Southern Interior Medical Research Inc.

    Kelowna, British Columbia, V1W 4V5

  • UroLaval

    Laval, Quebec, H7G 2E6

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Stanley Flax Medical Professional Corp.

    North York, Ontario, M2J 1V1

  • The Fe/Male Health Centres

    Oakville, Ontario, L6H 3P1

  • The Fe/Male Health Centre

    Oakville, Ontario, L6H 3P1

  • Kawartha Urology

    Peterborough, Ontario, K9H 1T6

  • Ultra-Med Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • CHU de Quebec - L'hotel-dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Centre de Recherche en Urologie de Lanaudiere

    Saint-Charles-Borromée, Quebec, J6E 9H3

  • Urology Clinic

    Scarborough Village, Ontario, M1S 4V5

  • Dr. Jonathan Chan Medical Professional Corp.

    Toronto, Ontario, M1V 0E3

  • Umesh Jain Medicine Professional Corp.

    Toronto, Ontario, M6S 4W4

  • Silverado Research Inc.

    Victoria, British Columbia, V8T 2C1

Other trials in Canada

About this study

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)

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

Read the 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.

Medical subject headings
Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 0 to Month 36

  2. 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.

    Measured: Month 0 to Month 36

  3. 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.

    Measured: Month 0 to Month 36

Secondary outcomes (7)

  1. 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.

    Measured: 3 Years

  2. 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.

    Measured: 3 Years

  3. 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.

    Measured: 3 Years

  4. 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)

    Measured: 3 Years

  5. 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.

    Measured: 3 Years

  6. # 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.

    Measured: 3 Years

  7. 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).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2019
  2. Study startNov 2013
  3. Primary completionNov 2019
  4. Study completionJul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
271 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057859
Sponsor's protocol ID
CMX-SC-2013-001
Acronym
ELIFIT
Status last verified
Jan 2022
First submitted
30 Jul 2015
Last updated
24 Jan 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of the Prostate, run by CMX Research at 23 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the patient quality of life (QoL) using the EORTC QLQ-C30 (time frame: Month 0 to Month 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04057859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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