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Prostatic NeoplasmsNCT03526562

Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients

A study testing Exercise in people with Prostatic Neoplasms and Exercise, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteBelgium
Study dates
15 Jan 2018to 15 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital ghent

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Exercise
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Exercise according to dose escalation

Study groups in NCT03526562
Study groupRoleWhat they receive
Single arm phase I trial with 3 exercise dose-escalation armsExperimentalexercise dose-escalation: aerobic, resistance and flexibility training
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose based on tolerance

    Maximum tolerated dose will be assessed by borg scale of perceived exertion.

    Measured: change before and after 1 exercise session (at one day)

  2. Maximum tolerated dose based on safety

    Maximum tolerated dose will be assessed by CTCAE

    Measured: change before and after 1 exercise session (at one day)

  3. Maximum tolerated dose based on safety

    Maximum tolerated dose will be assessed by VAS

    Measured: change before and after 1 exercise session (at one day)

Secondary outcomes (16)

  1. Functionality

    Functionality will be assessed by the Karnofsky Performance Status

    Measured: baseline

  2. Pain

    Pain will be assessed by the Brief pain inventory (BPI) questionnaire

    Measured: baseline

  3. Health Related quality of Life general

    HRQoL will be assessed by the EORTC quality of life (QLQ) C30 questionnaire

    Measured: baseline

  4. Health Related quality of Life disease specific

    HRQoL will be assessed by the EORTC quality of life prostate 25 questionnaire

    Measured: baseline

  5. Physical activity level by International Physical Activity Questionnaire (IPAQ)

    Physical activity level will be assessed by the IPAQ questionnaire

    Measured: baseline

  6. Physical activity level by Godin

    Physical activity level will be assessed by the Godin Leisure questionnaire

    Measured: baseline

  7. Body composition

    Body composition will be assessed by 8-point bioelectrical impedance analysis

    Measured: baseline

  8. Physical performance

    Physical performance will be assessed by the 400m walk test

    Measured: baseline

  9. Physical performance by time up and go

    Physical performance will be assessed by the time up and go test

    Measured: baseline

  10. Physical performance by 6m walk

    Physical performance will be assessed by the 6-meter walk test usual and fast pace

    Measured: baseline

  11. Physical performance by 6 m walk backward

    Physical performance will be assessed by the 6 meter backward walk

    Measured: baseline

  12. Physical performance by Cardiopulmonary Exercise Testing (CPET)

    Physical performance will be assessed by the CPET

    Measured: baseline

  13. Balance by four square test

    Balance will be assessed by the four square test

    Measured: baseline

  14. Balance by chair rise test

    Balance will be assessed by the chair rise test

    Measured: baseline

  15. Motivation 1

    Motivation will be assessed by the stages of change theory

    Measured: baseline

  16. Motivation 2

    Motivation will be assessed by the Exercise Motivation Inventory questionnaire

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study start15 Jan 2018
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
phase I study with an exercise prescription as intervention
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03526562
Sponsor's protocol ID
EC/2017/1099
Status last verified
Dec 2022
First submitted
28 Mar 2018
Last updated
23 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Prostatic Neoplasms and Exercise, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose based on tolerance (time frame: change before and after 1 exercise session (at one day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.

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