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

CMX Research

Status: Completed

Conditions: Cancer of the Prostate

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04057859

CMX-SC-2013-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 271 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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