NCT03526562

Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients

Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients: a Phase I Prescription Dose Escalation Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Neoplasms
• Exercise
• Castration-resistant Prostate Cancer
• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	Exercise according to dose escalation

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2018-05-16
• Last updated: 2022-12-23

Locations

1 site across 1 country: Belgium