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Trial Title:
SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy
NCT ID:
NCT06282185
Condition:
Prostatic Neoplasms
Metastasis
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized controlled trial with an intervention arm and an usual care group
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Physiotherapy
Description:
supervised training program for twelve weeks + usual care + advice about exercise
Arm group label:
intervention
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Canisius Wilhelmina Ziekenhuis (CWZ)
Address:
City:
Nijmegen
Zip:
6532SZ
Country:
Netherlands
Start date:
November 1, 2024
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Canisius-Wilhelmina Hospital
Agency class:
Other
Source:
Canisius-Wilhelmina Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282185
