Clinical trial NCT03526562: Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients
Official title: Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients: a Phase I Prescription Dose Escalation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Exercise
Castration-resistant Prostate Cancer
Physical Activity
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: phase I study with an exercise prescription as intervention
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* CRPC patients with second-line hormone treatment
* Able to walk 400 meters without help from another person
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)
* ≥4 weeks since any major surgery and fully recovered before patient registration
* Written informed consent must be given according to International conference on harmonization Good Clinical Practice and national regulation.

Exclusion Criteria:

* Musculoskeletal, cardiovascular or neurological comorbidity that prevent the patient to participate in an exercise program
* Painful bone metastases (VAS) at the time of inclusion
* Unstable bone metastases (SINS classification) at time of inclusion

Primary outcomes:
measure: Maximum tolerated dose based on tolerance
timeFrame: change before and after 1 exercise session (at one day)
measure: Maximum tolerated dose based on safety
timeFrame: change before and after 1 exercise session (at one day)
measure: Maximum tolerated dose based on safety
timeFrame: change before and after 1 exercise session (at one day)
Secondary outcomes:
measure: Functionality
timeFrame: baseline
measure: Pain
timeFrame: baseline
measure: Health Related quality of Life general
timeFrame: baseline
measure: Health Related quality of Life disease specific
timeFrame: baseline
measure: Physical activity level by International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline
measure: Physical activity level by Godin
timeFrame: baseline
measure: Body composition
timeFrame: baseline
measure: Physical performance
timeFrame: baseline
measure: Physical performance by time up and go
timeFrame: baseline
measure: Physical performance by 6m walk
timeFrame: baseline
measure: Physical performance by 6 m walk backward
timeFrame: baseline
measure: Physical performance by Cardiopulmonary Exercise Testing (CPET)
timeFrame: baseline
measure: Balance by four square test
timeFrame: baseline
measure: Balance by chair rise test
timeFrame: baseline
measure: Motivation 1
timeFrame: baseline
measure: Motivation 2
timeFrame: baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital ghent
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Piet Ost, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: