Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

NCT ID: NCT03365076

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2023-01-05

Brief 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.

Detailed 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).

Conditions

Prostate Cancer; Physical Activity; Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical aerobic intervention

The exercise program will be varying between different aerobic activities indoor or outdoor as walking uphill and in stairs in intervals that will differ from session to session to build up the load and progression for these patients. In total, each session will be lasting approximately 45-60 minutes and a physiotherapist or personal trainer will supervise each session. Depending on the participants starting point, there will be 3 supervised session per week and two sessions where the participants do activity with low intensity (walk) by themselves and keep a log with duration (time) and intensity (using Borg scale).

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

Aerobic physical activity as stated in Arm A

Controls

These patients will be acting as controls by not been instructed to physical activity. We will not monitor their activity either as this has been shown to increase activity by itself.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity

Aerobic physical activity as stated in Arm A

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: collaborator

Northern Health Authority

OTHER_GOV

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigve Andersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UNN HF Tromsø

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

2015/1791

Identifier Type: -

Identifier Source: org_study_id