Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

Prostate Cancer Clinical Trial

— EXIPOX  

Official title:

Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03365076
• Other study ID #: 2015/1791
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 5, 2023

Study information

• Verified date: January 2023
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous research into metabolic and hypoxic markers has found evidence of preclinical impact of exercise on prostate tumor blood flow and oxygenation in rodents . As radiotherapy is a frequently used and effective therapy for and that sufficient oxygenation is decisive to the effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve treatment efficacy of radiotherapy in prostate cancer is put forward. This study has a potential challenging intervention, but a potential very high gain as it includes active patient participation to significantly improve outcome of radical radiotherapy.

Description:

A randomized controlled trial with four to five weeks of moderate/high intensity aerobic exercise program compared with no intervention for 32 prostate cancer patients waiting for radical prostatectomy at the University Hospital of North Norway (UNN). 16 patients will undergo the intervention. The expression of the hypoxic marker pimonidazole in the prostate specimens of intervention groups and the control groups will be assessed. This method is considered a reliable tissue oxygenation measurement technique. These patients will also have their and blood flow and hypoxia measured in prostate cancers through magnetic resonance imaging (MRIs).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed PC
• planned radical prostatectomy
• informed consent given
• above 18 years of age
• BMI < 30
• non-smoker
• living in Tromso region

Exclusion Criteria:

• Contraindications to the intervention like;
• heart failure,
• angina pectoris,
• respiratory disease limiting possible intervention
• use of physical supportive devices to aid movement
• High level of physical activity
• smoking
• BMI>30

Related Conditions & MeSH terms

• Hypoxia
• Physical Activity
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Physical activity
Aerobic physical activity as stated in Arm A

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of North Norway	Northern Health Authority, Oslo University Hospital, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxic fraction-gold standard	We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole	through study completion, an average of 1 year
Secondary	Side effects	We will use the Expanded Prostate Cancer Index Composite (EPIC) designed to evaluate patient function and side effects after PC treatment in both groups	through study completion, an average of 1 year
Secondary	Hypoxic fraction-MRI	We will try to explore the hypoxic fraction by use of magnetic resonance imaging	through study completion, an average of 1 year
Secondary	Health related Quality of life	We will use EORTC-QLQ30 which is a validated instrument designed to measure quality of life in prostate cancer in both groups	through study completion, an average of 1 year