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

Prostatic Neoplasms Clinical Trial

— Superman  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06282185
• Other study ID #: CanisiusWH
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2024
• Source: Canisius-Wilhelmina Hospital
• Contact: stijn Elbers, MD
• Phone: (+31)243657657
• Email: s.elbers[@]cwz.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastasis
• Prostatic Neoplasms

Intervention

Other:
• Physiotherapy
supervised training program for twelve weeks + usual care + advice about exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Canisius-Wilhelmina Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of quality of life assessed with EPIC26 (0-100 points)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.	6 months
Primary	change of quality of life assessed with EPIC26 (0-100 points)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.	3 months
Primary	change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.	6 months
Primary	change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.	3 months
Secondary	change of physical fitness in maximum uptake of oxygen in ml/kg/min	Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness in patients with metastatic prostate cancer compared to usual care.	6 months
Secondary	change of physical fitness in maximum uptake of oxygen in ml/kg/min	Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness and body composition in patients with metastatic prostate cancer compared to usual care.	3 months
Secondary	change of physical fitness in fat percentage	change in body composition in patients with metastatic prostate cancer compared to usual care.	3 months
Secondary	change of physical fitness in fat percentage	change in body composition in patients with metastatic prostate cancer compared to usual care.	6 months
Secondary	change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning.	3 months
Secondary	change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning.	6 months