Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox) (EXIPOX)

University Hospital of North Norway

Status: Terminated

Conditions: Physical Activity; Hypoxia; Prostate Cancer

Treatments: Other: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03365076

2015/1791

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1 patient

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Physical aerobic intervention

Experimental group

Description:

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).

Treatment:

Other: Physical activity

Controls

No Intervention group

Description:

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.