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

• ClinicalTrials.gov Identifier: NCT03365076
• Recruitment Status: Suspended
• First Posted: December 7, 2017
• Last Update Posted: September 14, 2021
• Sponsor: University Hospital of North Norway
• Collaborators: Oslo University Hospital; University of Tromso; Northern Health Authority
• Information provided by (Responsible Party): University Hospital of North Norway

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Physical Activity; Hypoxia	Other: Physical activity	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open label randomized control trial. Randomization 1:1
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exercise for Improving Prostate Oxygenation in Prostate Tumores (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy
• Actual Study Start Date: May 1, 2018
• Estimated Primary Completion Date: November 1, 2021
• Estimated Study Completion Date: November 1, 2021

Arms and Interventions

Arm	Intervention/treatment
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; Aerobic physiocal activity as stated in Arm A
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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Side effects [ Time Frame: through study completion, an average of 1 year ]
   We will use the Expanded Prostate Cancer Index Composite (EPIC) designed to evaluate patient function and side effects after PC treatment in both groups
2. Hypoxic fraction-MRI [ Time Frame: through study completion, an average of 1 year ]
   We will try to explore the hypoxic fraction by use of magnetic resonance imaging
3. Healt related Quality of life [ Time Frame: through study completion, an average of 1 year ]
   We will use EORTC-QLQ30 which is a validated instrument designed to measure quality of life in prostate cancer in both groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Norway

University Hospital of North Norway

Tromsø, Norway, 9038

Sponsors and Collaborators

University Hospital of North Norway

Oslo University Hospital

University of Tromso

Northern Health Authority

Investigators

• Principal Investigator: Sigve Andersen, MD, PhD; UNN HF Tromsø

More Information

• Responsible Party: University Hospital of North Norway
• ClinicalTrials.gov Identifier: NCT03365076
• Other Study ID Numbers: 2015/1791
• First Posted: December 7, 2017
• Last Update Posted: September 14, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypoxia; Signs and Symptoms, Respiratory