Not provided
Not provided
Not provided
Not provided
Slow inclusion rate due to patients operated before intervention is implementable
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| University of Tromso | OTHER |
| Northern Health Authority | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical aerobic intervention | Experimental | 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). |
|
| Controls | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Other | Aerobic physical activity as stated in Arm A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxic fraction-gold standard | We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hypoxic fraction-MRI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Contraindications to the intervention like;
High level of physical activity
smoking
BMI>30
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sigve Andersen, MD, PhD | UNN HF Tromsø | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | 9038 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Open label randomized control trial. Randomization 1:1
Not provided
Not provided
Not provided
Not provided
We will try to explore the hypoxic fraction by use of magnetic resonance imaging
| 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 | through study completion, an average of 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |