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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03526562
Other study ID # EC/2017/1099
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date June 15, 2018

Study information

Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date June 15, 2018
Est. primary completion date June 15, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Exercise
Exercise according to dose escalation

Locations

Country Name City State
Belgium University Hospital ghent Ghent Oost-Vlaanderen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose based on tolerance Maximum tolerated dose will be assessed by borg scale of perceived exertion. change before and after 1 exercise session (at one day)
Primary Maximum tolerated dose based on safety Maximum tolerated dose will be assessed by CTCAE change before and after 1 exercise session (at one day)
Primary Maximum tolerated dose based on safety Maximum tolerated dose will be assessed by VAS change before and after 1 exercise session (at one day)
Secondary Functionality Functionality will be assessed by the Karnofsky Performance Status baseline
Secondary Pain Pain will be assessed by the Brief pain inventory (BPI) questionnaire baseline
Secondary Health Related quality of Life general HRQoL will be assessed by the EORTC quality of life (QLQ) C30 questionnaire baseline
Secondary Health Related quality of Life disease specific HRQoL will be assessed by the EORTC quality of life prostate 25 questionnaire baseline
Secondary Physical activity level by International Physical Activity Questionnaire (IPAQ) Physical activity level will be assessed by the IPAQ questionnaire baseline
Secondary Physical activity level by Godin Physical activity level will be assessed by the Godin Leisure questionnaire baseline
Secondary Body composition Body composition will be assessed by 8-point bioelectrical impedance analysis baseline
Secondary Physical performance Physical performance will be assessed by the 400m walk test baseline
Secondary Physical performance by time up and go Physical performance will be assessed by the time up and go test baseline
Secondary Physical performance by 6m walk Physical performance will be assessed by the 6-meter walk test usual and fast pace baseline
Secondary Physical performance by 6 m walk backward Physical performance will be assessed by the 6 meter backward walk baseline
Secondary Physical performance by Cardiopulmonary Exercise Testing (CPET) Physical performance will be assessed by the CPET baseline
Secondary Balance by four square test Balance will be assessed by the four square test baseline
Secondary Balance by chair rise test Balance will be assessed by the chair rise test baseline
Secondary Motivation 1 Motivation will be assessed by the stages of change theory baseline
Secondary Motivation 2 Motivation will be assessed by the Exercise Motivation Inventory questionnaire baseline
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