Feasibility and Safety of Physical Exercise in Men With Prostate Cancer — PCa_Ex  

Prostate Cancer Clinical Trial

Official title: Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy

Status Completed

Clinical Trial Summary

Prostate cancer (PCa) is among the most widespread in the male population and represents 19% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) and Radiotherapy (RT) are used for increase survival. However, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to an increase risk of accidental falls and fractures.

Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce several side effects of therapies. However, most people living with cancer do not meet current exercise recommendations.

Indeed, an effective PE program requires the application of long-term, moderate to high intensity activity. Thus it may be difficult to implement this type of recommendation in patient with PCa.

Therefore, this study aims to develop an experimental PE intervention testing their feasibility and safety and the patients' satisfaction, aimed at improving the health conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and fracture events will be monitored.

Clinical Trial Description

The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program.

Secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of life.

The PE program will be conducted at the "Virgilio Camparada" Municipal Athletic Track in the city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program with three sessions per week, for eight weeks. Subsequently, the intervention will continue further for four weeks maintaining one supervised session and two unsupervised sessions a week. Finally, sessions will be performed without supervision for further eight weeks. The overall duration of the intervention will be twenty weeks. In addition, an evaluation will be performed at one year from baseline to monitor long-term fall and fracture events.

At baseline will be the following assessment:

• clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the intensity of aerobic exercise. ;

Related Conditions & MeSH terms

• Androgen Deprivation Therapy
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy

• NCT number: NCT04500080
• Study type: Interventional
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Completion date: September 30, 2022