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Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox) (EXIPOX)

Primary Purpose

Prostate Cancer, Physical Activity, Hypoxia

Status

Terminated

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Physical activity

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical aerobic intervention

Controls

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Hypoxic fraction-gold standard

We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole

Secondary Outcome Measures

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

Hypoxic fraction-MRI

We will try to explore the hypoxic fraction by use of magnetic resonance imaging

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

Full Information

NCT ID

NCT03365076

First Posted

October 6, 2017

Last Updated

January 5, 2023

Sponsor

University Hospital of North Norway

Collaborators

Oslo University Hospital, University of Tromso, Northern Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT03365076

Brief Title

Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

Acronym

EXIPOX

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Slow inclusion rate due to patients operated before intervention is implementable

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

January 5, 2023 (Actual)

Study Completion Date

January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital of North Norway

Collaborators

Oslo University Hospital, University of Tromso, Northern Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Physical Activity, Hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Open label randomized control trial. Randomization 1:1

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical aerobic intervention

Arm Type

Experimental

Arm Description

Arm Title

Controls

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Physical activity

Intervention Description

Aerobic physical activity as stated in Arm A

Primary Outcome Measure Information:

Title

Hypoxic fraction-gold standard

Description

We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Side effects

Description

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

Title

Hypoxic fraction-MRI

Description

We will try to explore the hypoxic fraction by use of magnetic resonance imaging

Time Frame

through study completion, an average of 1 year

Title

Health related Quality of life

Description

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosed PC planned radical prostatectomy informed consent given above 18 years of age BMI < 30 non-smoker living in Tromso region Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sigve Andersen, MD, PhD

Organizational Affiliation

UNN HF Tromsø

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of North Norway

City

Tromsø

ZIP/Postal Code

9038

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

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