Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526562
• Other study ID #: EC/2017/1099
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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