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

Azienda Unità Sanitaria Locale Reggio Emilia

Status: Completed

Conditions: Androgen Deprivation Therapy; Radiotherapy; Prostate Cancer

Treatments: Behavioral: PE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04500080

520/2020/SPER/IRCCSRE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically documented diagnosis of PCa;
• Undergo ADT and RT during the study period;
• At least 18 years old;
• Willing and able to give written informed consent;
• Able to read and understand Italian Language;

Exclusion criteria

• Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

PE intervention

Experimental group

Description:

Aerobic, resistance, and neuromotor exercise

Treatment:

Behavioral: PE Intervention