An interventional study of Physical activity in Prostate Cancer, Physical Activity and Hypoxia, sponsored by University Hospital of North Norway. Terminated at 1 site in Norway. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Contraindications to the intervention like;
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).
Other: Physical activity
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.
Aerobic physical activity as stated in Arm A
Hypoxic fraction-gold standard
We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
Hypoxic fraction-MRI
We will try to explore the hypoxic fraction by use of magnetic resonance imaging
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University Hospital of North Norway