Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

NCT03365076 | Terminated

• 1 other identifier: 2015/1791
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Physical Activity; Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Side effects

  through study completion, an average of 1 year

• Hypoxic fraction-MRI

  through study completion, an average of 1 year

• Health related Quality of life

  through study completion, an average of 1 year

Study Arms (2)

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).

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.

Interventions

Physical activity OTHER

Aerobic physical activity as stated in Arm A

Physical aerobic intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Oslo University Hospital: collaborator
• University of Tromso: collaborator
• Northern Health Authority: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity; Hypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sigve Andersen, MD, PhD

  UNN HF Tromsø

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label randomized control trial. Randomization 1:1

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: December 7, 2017
• Study Start: May 1, 2018
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)