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TerminatedNCT03365076EXIPOXUpdated Jan 9, 2023

Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

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

Why this study was terminated
Slow inclusion rate due to patients operated before intervention is implementable
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 85 studies in Prostatic Neoplasms with a site in Norway — 16 open to participants now, 27 under way, 9 of them phase 3. Prostatic Neoplasms · Norway.

Enrollment
65th of 66
1 · median 383
Started
2018
with 3 others
No phase
23 of 85
4 open now
Registered
51st of 85
by date

Among the 85 studies in Prostatic Neoplasms with a site in Norway, this one is the 65th largest by enrollment of the 66 interventional ones that give a count, is one of 4 that started in 2018, is one of 23 with no phase, and was the 51st registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

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Open to participants now

16 of the 85 studies in Prostatic Neoplasms with a site in Norway are open now. Recruiting first, the newest first:

11 more — sign in →

All 16 open studies →

A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

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02

Study 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.

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).

03

Conditions studied

  • Prostate Cancer
  • Physical Activity
  • Hypoxia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosed PC
  • planned radical prostatectomy
  • given
  • above 18 years of age
  • \< 30
  • non-smoker
  • living in Tromso region

Exclusion criteria

Exclusion Criteria:

  • 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
  • >30
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Physical aerobic intervention

    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

  • No intervention
    Controls

    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.

Interventions

  • OtherPhysical activity

    Aerobic physical activity as stated in Arm A

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • University Hospital of North Norway
    Tromsø, 9038, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Jan 2023, 56 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2017
First posted
Dec 7, 2017
StartActual
May 1, 2018
Primary completionActual
Jan 5, 2023
CompletionActual
Jan 5, 2023
Last update
Jan 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03365076
Collaborators
Oslo University Hospital, University of Tromso, Northern Health Authority
Responsible party
Sponsor
First posted
Dec 7, 2017
Start date
May 1, 2018
Primary completion
Jan 5, 2023
Completion
Jan 5, 2023
Last update
Jan 9, 2023

Study contacts

Sigve Andersen, MD, PhD
principal investigator · UNN HF Tromsø

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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