Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
NCT02003924
Cancer of the Prostate, Genital Diseases
Tucson, Arizona, United States
View Trial DetailsNCT Number: NCT04057859
The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
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Notify Me18 year and older
Male
Observational
Southern Interior Medical Research Inc., Kelowna, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Month 0 to Month 36
The EORTC QLQ-C30 is a questionnaire designed to measure quality of life of cancer patient.
Time frame: Month 0 to Month 36
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.
Time frame: Month 0 to Month 36
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.
Time frame: 3 Years
To determine the compliance of home-based exercises and regular physical activities using a weekly activity log.
Time frame: 3 Years
To determine the impact of exercise and physician support on activity levels using the weekly activity log, home diary or NIKE+ Fuelband.
Time frame: 3 Years
To determine if BMI (body mass index) scores decrease with nutritional guidance and exercise with physician support.
Time frame: 3 Years
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)
Time frame: 3 Years
Safety and tolerability will be assessed based on the number and type of adverse events collected over the study duration.
Time frame: 3 Years
To determine # of patients who discontinued ADT therapy over the course of the study with reasons describing why.
Time frame: 3 years
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).
CMX Research
Other
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)
Acronym: ELIFIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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