Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03526562
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2018-03-28
Brief Title:
Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients a Phase I Prescription Dose Escalation Trial
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent drug improvement eg 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 eg sedentary behavior SB could have a positive impact on patients 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
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 33 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 65-80HRmax 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None