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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms; Physical Activity; Exercise; Castration-resistant Prostate Cancer
• Intervention / Treatment: Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm phase I trial with 3 exercise dose-escalation arms; exercise dose-escalation: aerobic, resistance and flexibility training	Behavioral: Exercise; Exercise according to dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Maximum tolerated dose based on safety	Maximum tolerated dose will be assessed by CTCAE	change before and after 1 exercise session (at one day)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	Functionality will be assessed by the Karnofsky Performance Status	baseline
Pain	Pain will be assessed by the Brief pain inventory (BPI) questionnaire	baseline
Health Related quality of Life general	HRQoL will be assessed by the EORTC quality of life (QLQ) C30 questionnaire	baseline
Health Related quality of Life disease specific	HRQoL will be assessed by the EORTC quality of life prostate 25 questionnaire	baseline
Physical activity level by International Physical Activity Questionnaire (IPAQ)	Physical activity level will be assessed by the IPAQ questionnaire	baseline
Physical activity level by Godin	Physical activity level will be assessed by the Godin Leisure questionnaire	baseline
Body composition	Body composition will be assessed by 8-point bioelectrical impedance analysis	baseline
Physical performance	Physical performance will be assessed by the 400m walk test	baseline
Physical performance by time up and go	Physical performance will be assessed by the time up and go test	baseline
Physical performance by 6m walk	Physical performance will be assessed by the 6-meter walk test usual and fast pace	baseline
Physical performance by 6 m walk backward	Physical performance will be assessed by the 6 meter backward walk	baseline
Physical performance by Cardiopulmonary Exercise Testing (CPET)	Physical performance will be assessed by the CPET	baseline
Balance by four square test	Balance will be assessed by the four square test	baseline
Balance by chair rise test	Balance will be assessed by the chair rise test	baseline
Motivation 1	Motivation will be assessed by the stages of change theory	baseline
Motivation 2	Motivation will be assessed by the Exercise Motivation Inventory questionnaire	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: EC/2017/1099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No