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

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.

Study Overview

• Status: Terminated
• Conditions: Hypoxia; Physical Activity; Prostate Cancer
• Intervention / Treatment: Other: Physical activity

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway, 9038
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 physical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Oslo University Hospital; University of Tromso; Northern Health Authority
• Investigators: Principal Investigator: Sigve Andersen, MD, PhD, UNN HF Tromsø

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Signs and Symptoms, Respiratory; Prostatic Neoplasms; Hypoxia
• Other Study ID Numbers: 2015/1791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No