Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)
- Conditions
- Prostate CancerHypoxiaPhysical Activity
- Interventions
- Other: Physical activity
- Registration Number
- NCT03365076
- Lead Sponsor
- University Hospital of North Norway
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 1
- diagnosed PC
- planned radical prostatectomy
- informed consent given
- above 18 years of age
- BMI < 30
- non-smoker
- living in Tromso region
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical aerobic intervention Physical activity 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).
- Primary Outcome Measures
Name Time Method Hypoxic fraction-gold standard through study completion, an average of 1 year We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole
- Secondary Outcome Measures
Name Time Method Health related Quality of life through study completion, an average of 1 year We will use EORTC-QLQ30 which is a validated instrument designed to measure quality of life in prostate cancer in both groups
Side effects through study completion, an average of 1 year We will use the Expanded Prostate Cancer Index Composite (EPIC) designed to evaluate patient function and side effects after PC treatment in both groups
Hypoxic fraction-MRI through study completion, an average of 1 year We will try to explore the hypoxic fraction by use of magnetic resonance imaging
Trial Locations
- Locations (1)
University Hospital of North Norway
🇳🇴Tromsø, Norway