Prostate CancerEXIPOXNCT03365076
Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)
A study testing Physical activity in people with Prostate Cancer and Physical Activity, run by University Hospital of North Norway at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Physical Activity, Hypoxia
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2018to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed PC
- planned radical prostatectomy
- informed consent given
- above 18 years of age
- BMI < 30
- non-smoker
- living in Tromso region
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy
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.
Read the 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
- Being tested
- Physical activity
- Medical subject headings
- Prostatic Neoplasms, Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Aerobic physical activity as stated in Arm A
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Physical activity |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxic fraction-gold standard
We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 May 2018
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Why it stopped: Slow inclusion rate due to patients operated before intervention is implementable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized control trial. Randomization 1:1
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Tromso, Northern Health Authority
- Responsible party
- Sponsor
- Investigators
- Sigve Andersen, MD, PhD, Principal investigator, UNN HF Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365076
- Sponsor's protocol ID
- 2015/1791
- Acronym
- EXIPOX
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2017
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy
- ClinicalTrials.gov ID
- NCT03365076
- Acronym / sponsor ID
- EXIPOX / 2015/1791
- Conditions
- Prostate Cancer, Physical Activity, Hypoxia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion rate due to patients operated before intervention is implementable
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University of Tromso, Northern Health Authority
- Study start
- 1 May 2018 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized control trial. Randomization 1:1
| Arm | Type | Receives |
|---|---|---|
| Physical aerobic intervention | Experimental | Other: Physical activityThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed PC
- planned radical prostatectomy
- informed consent given
- above 18 years of age
- BMI < 30
Key exclusion criteria (8 listed)
- Contraindications to the intervention like;
- High level of physical activity
- smoking
- BMI>30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAerobic physical activity as stated in Arm A | Other | Physical aerobic intervention |
Primary outcome
Hypoxic fraction-gold standard
Time frame: through study completion, an average of 1 year
We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole
3 secondary outcomes
Side effects
Time frame: through study completion, an average of 1 year
Hypoxic fraction-MRI
Time frame: through study completion, an average of 1 year
Health related Quality of life
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Slow inclusion rate due to patients operated before intervention is implementable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigve Andersen, MD, PhD principal investigator
UNN HF Tromsø
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Prostate Cancer and Physical Activity, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow inclusion rate due to patients operated before intervention is implementable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxic fraction-gold standard (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.