Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients

NCT03526562 | Completed

• 1 other identifier: EC/2017/1099
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Functionality

  baseline

• Pain

  baseline

• Health Related quality of Life general

  baseline

• Health Related quality of Life disease specific

  baseline

• Physical activity level by International Physical Activity Questionnaire (IPAQ)

  baseline

Study Arms (1)

Single arm phase I trial with 3 exercise dose-escalation arms

EXPERIMENTAL

exercise dose-escalation: aerobic, resistance and flexibility training

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Exercise according to dose escalation

Single arm phase I trial with 3 exercise dose-escalation arms

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Musculoskeletal, cardiovascular or neurological comorbidity that prevent the patient to participate in an exercise program

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Piet Ost, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: phase I study with an exercise prescription as intervention

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 16, 2018
• Study Start: January 15, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

BE (1)