Clinical trial NCT06282185: SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
Official title: SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Prostatic Neoplasms
Metastasis
Lead sponsor: Canisius-Wilhelmina Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with an intervention arm and an usual care group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: change of quality of life assessed with EPIC26 (0-100 points)
timeFrame: 6 months
measure: change of quality of life assessed with EPIC26 (0-100 points)
timeFrame: 3 months
measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
timeFrame: 6 months
measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)
timeFrame: 3 months
Secondary outcomes:
measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min
timeFrame: 6 months
measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min
timeFrame: 3 months
measure: change of physical fitness in fat percentage
timeFrame: 3 months
measure: change of physical fitness in fat percentage
timeFrame: 6 months
measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))
timeFrame: 3 months
measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis (CWZ)
state: Gelderland
Study officials:
affiliation: Canisius Wilhelmina Ziekenhuis (CWZ)
name: Jean-Paul van Basten, Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: