Recent drug improvement (e.g. abiraterone or enzalutamide) for castration resistant prostate cancer (CRPC) patients has improved survival. As treatment strategies improve and patients live longer, patients must cope with their treatment-induced adverse effects. Improving levels of physical activity (PA) and less amounts of sitting time (e.g. sedentary behavior, SB) could have a positive impact on patient's health, non-cancer mortality, and quality of life and potentially improve survival. The role of PA has not yet been examined in CRPC patients, which is a clear unmet need. No specific PA guidelines exist for CRPC patients, but specific guidelines are warranted because of advanced disease stage, reduced performance score and comorbidity. It is to be expected that the PA level of CRPC patients is lower compared to non-CRPC patients receiving androgen deprivation therapy (ADT). This study aims to determine the optimal starting physical therapy prescription in CRPC patients receiving second line hormone treatment.
CRPC patients receiving second-line hormone treatment at Ghent University Hospital are invited to participate in this phase I 3+3 dose escalation design (escalation to next exercise dose per 3 study patients). The prescription start dose is 15min. aerobic training (50-80% maximum heart rate (HRmax). warm-up and cooling-down and 65-80%HRmax. core), 1 set with 8-10 reps. resistance training (50-60% one repetition maximum (1RM), 8 exercises) and 1 set (30s.) with 2 reps. flexibility training (5 exercises). Factors determining compliance for the dose are tolerance and safety. Tolerance for the exercise prescription will be assessed with the Borg scale of perceived exertion after every exercise. Compliant for tolerance is a score ≤16. Safety will be assessed by the visual analogue scale (VAS) (assessed by the patient) for pain and the CTCAE criteria (assessed by a trained health care provider) for bone pain after every exercise. Compliant for safety is ≤3 VAS for exercise-induced pain and \<grade 2 according to the CTCAE criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Exercise according to dose escalation
University Hospital ghent
Ghent, Oost-Vlaanderen, Belgium
Maximum tolerated dose based on tolerance
Maximum tolerated dose will be assessed by borg scale of perceived exertion.
Time frame: change before and after 1 exercise session (at one day)
Maximum tolerated dose based on safety
Maximum tolerated dose will be assessed by CTCAE
Time frame: change before and after 1 exercise session (at one day)
Maximum tolerated dose based on safety
Maximum tolerated dose will be assessed by VAS
Time frame: change before and after 1 exercise session (at one day)
Functionality
Functionality will be assessed by the Karnofsky Performance Status
Time frame: baseline
Pain
Pain will be assessed by the Brief pain inventory (BPI) questionnaire
Time frame: baseline
Health Related quality of Life general
HRQoL will be assessed by the EORTC quality of life (QLQ) C30 questionnaire
Time frame: baseline
Health Related quality of Life disease specific
HRQoL will be assessed by the EORTC quality of life prostate 25 questionnaire
Time frame: baseline
Physical activity level by International Physical Activity Questionnaire (IPAQ)
Physical activity level will be assessed by the IPAQ questionnaire
Time frame: baseline
Physical activity level by Godin
Physical activity level will be assessed by the Godin Leisure questionnaire
Time frame: baseline
Body composition
Body composition will be assessed by 8-point bioelectrical impedance analysis
Time frame: baseline
Physical performance
Physical performance will be assessed by the 400m walk test
Time frame: baseline
Physical performance by time up and go
Physical performance will be assessed by the time up and go test
Time frame: baseline
Physical performance by 6m walk
Physical performance will be assessed by the 6-meter walk test usual and fast pace
Time frame: baseline
Physical performance by 6 m walk backward
Physical performance will be assessed by the 6 meter backward walk
Time frame: baseline
Physical performance by Cardiopulmonary Exercise Testing (CPET)
Physical performance will be assessed by the CPET
Time frame: baseline
Balance by four square test
Balance will be assessed by the four square test
Time frame: baseline
Balance by chair rise test
Balance will be assessed by the chair rise test
Time frame: baseline
Motivation 1
Motivation will be assessed by the stages of change theory
Time frame: baseline
Motivation 2
Motivation will be assessed by the Exercise Motivation Inventory questionnaire
Time frame: baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.