SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy

NCT ID: NCT06282185

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-05-01

Brief Summary

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The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:

* What is the impact of exercise on quality of life
* What is the impact of exercise on physical fitness

Participants will have an individual training program with supervised training by physiotherapists.

Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.

Detailed Description

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Conditions

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Prostatic Neoplasms Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial with an intervention arm and an usual care group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise.

Study Groups

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intervention

supervised training program for twelve weeks + usual care + advice about exercise

Group Type EXPERIMENTAL

Physiotherapy

Intervention Type OTHER

supervised training program for twelve weeks + usual care + advice about exercise

usual care

usual care + advice about exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physiotherapy

supervised training program for twelve weeks + usual care + advice about exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age \> 18 years old
* Able to read and complete questionnaires in Dutch
* Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)

Exclusion Criteria

* Other cancers
* Clinicians' judgement
* Age \>80 years old or not able to walk 400m
* Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
* Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
* Spinal cord compression, history of pathological fractures
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Canisius-Wilhelmina Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul van Basten, Dr. MD

Role: PRINCIPAL_INVESTIGATOR

Canisius Wilhelmina Ziekenhuis (CWZ)

Locations

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Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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CanisiusWH

Identifier Type: -

Identifier Source: org_study_id

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