Prostate CancerSHOR-TESTNCT03675529
The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy.
A study testing High Intensity Interval Training bout in people with Prostate Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background and purpose: The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer undergoing radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High Intensity Interval Training bout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 24 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with histologically verified localized prostate adenocarcinoma undergoing curative intended radical prostatectomy.
Who cannot join
- Age: <18 years
- Any other known malignancy requiring active treatment
- Performance status > 1
- Allergy to pimonidazole
- Ongoing treatment with beta blockers
- Physical disabilities precluding physical testing and/or exercise
- Inability to read and understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, DK-2100
About this study
Official title: The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study
Background and purpose: The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer undergoing radical prostatectomy.
The primary hypothesis is that exercise reduces tumor hypoxia and that the reduction is greater in patients performing one acute high intensity exercise bout compared to no training controls.
Read more
The investigators have not been able to identify any prior or current randomized trials investigating exercise and tumor hypoxia, and believe that such research is warranted and would be of great importance. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.
Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.
Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either one single acute High Intensity Interval Training bout or usual care and no training the day prior to radical prostatectomy.
All patients will undergo assessment at inclusion (baseline) and the day prior to surgery.
Assessment includes: anthropometrics; blood pressure; resting hearth rate; hip and waist circumference, ECG, quality of life by self-report questionnaires; fasting blood sample measuring PSA (prostate specific antigen), cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose and inflammatory markers.
All patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate.
Biological tissue from tumor (primary prostate biopsies) will also be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.
Read the detailed description
The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer randomized to one single acute I) High Intensity Interval Training bout compared to (II) usual care and no training prior to radical prostatectomy.
In addition to this the aim is to investigate the effect of one exercise bout on tumor vessel morphology and to investigate the effect of one acute exercise bout on intratumoral immune cell infiltration and to investigate the modulation of tumor-metabolism, -biology and signaling in patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.
Moreover this study will explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session, and will collect physiological (metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) information regarding patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.
- Conditions
- Prostate Cancer
- Being tested
- High Intensity Interval Training bout
- Keywords
- prostate neoplasm, exercise, high intensity interval training, tumor hypoxia, immune cells
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training boutBehavioural
Patients randomized to the HIIT bout will perform one single supervised High Intensity Interval Training bout consisting firstly of a wattmax test on a stationary bike, in order to set the training intensity. This is followed by 10 minutes at low intensity at approximately 30% of wattmax. Subsequently patients will perform 16 min with 4 cycles with High and Low intensity. HI intervals consisting of 1 min with 100% of wattmax followed by 3 min recovery with the intensity load of 30% of wattmax.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training bout | Experimental | Patients randomized to this group will perform a wattmax test immediately followed by 4 intervals of high and low intensity based on percentage of wattmax. Immediately after the exercise bout is finished patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day. Receives: Behavioral: High Intensity Interval Training bout |
| Controls (usual care) | No intervention | Patients randomized to the control group will not be doing any exercise, but will after approximately 35 min from baseline blood sampling receive one dose of pimonidazole hydrochloride (500 mg per m2 bodysurface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor hypoxia
Quantification of tumor hypoxia will be assessed using pimonidazole staining
Measured: At prostatectomy
Secondary outcomes (18)
Intratumoral immune cell infiltration
Intratumoral immune cell infiltration will be quantified using histological analyses
Measured: Primary prostate biopsies and until radical prostatectomy
Tumor vessel morphology
Tumor vessel morphology will be evaluated using histological analyses
Measured: Primary prostate biopsies and until radical prostatectomy
Tumor metabolism-, biology and signaling
Tumor samples will undergo proteomic analyses in order to uncover potential upregulated biomarkers
Measured: Primary prostate biopsies and until radical prostatectomy
Changes in immune cells during an acute exercise bout
Changes in immune cells during an acute exercise bout will be measured in blood samples using flowcytometry
Measured: From start of exercise bout and until 60 minutes post exercise
Changes in epinephrine concentration
Concentration of epinephrine will be measured in blood samples by radioimmunoassay analyses.
Measured: From start of exercise bout and until 60 minutes post exercise
Changes in nor-epinephrine concentration
Concentration of nor-epinephrine will be measured in blood samples by radioimmunoassay analyses.
Measured: From start of exercise bout and until 60 minutes post exercise
Changes in various interleukines
Concentration of various interleukines will be measured in blood samples by measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: From start of exercise bout and until 60 minutes post exercise
Changes in Tumor Necrosis Factor alpha (TNFa) concentration
Concentrations of TNFa will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: From start of exercise bout and until 60 minutes post exercise
Changes in Interferon Gamma (IFNγ) concentration
Concentrations of IFNγ will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.
Measured: From start of exercise bout and until 60 minutes post exercise
Concentration of C-reactive Protein (CRP)
Concentration of CRP will be measured in fasting blood sample by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Total plasma cholesterol concentration
Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Plasma LDL-Cholesterol concentration
Concentrations of LDL- cholesterol will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Plasma HDL-Cholesterol concentration
Concentrations of HDL- cholesterol will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Plasma triglyceride concentrations
Concentrations of triglycerides will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
HbA1C concentration
Concentrations of HbA1C will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Plasma Insulin concentration
Concentrations of insulin will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Plasma Glucose concentration
Concentrations of glucose will be measured in fasting blood samples by standard laboratory methods.
Measured: Blood sampling on the day of radical prostatectomy
Wattmax-test
The participants in the HIIT group will undergo a maximal graded exercise test on a bicycle ergometer for evaluation of cardiovascular function and determination of the maximum watt (wattmax). The test starts with a 3 min warm up at 70 watt (the watts may have to be adjusted to the individual fitness level). Warm up is immediately followed by a 20 watt increase every 1 min until exhaustion. The maximum watt will be calculated.
Measured: At baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Oct 2018
- Primary completion24 Nov 2019
- Study completion24 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sissal Sigmundsdóttir Djurhuus, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Sissal S Djurhuus, MD, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675529
- Sponsor's protocol ID
- H-18020711
- Acronym
- SHOR-TEST
- Status last verified
- Dec 2019
- First submitted
- 24 Aug 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Djurhuus SS, Schauer T, Simonsen C, Toft BG, Jensen ARD, Erler JT, Roder MA, Hojman P, Brasso K, Christensen JF. Effects of acute exercise training on tumor outcomes in men with localized prostate cancer: A randomized controlled trial. Physiol Rep. 2022 Oct;10(19):e15408. doi: 10.14814/phy2.15408.
PubMed 36199257Schauer T, Djurhuus SS, Simonsen C, Brasso K, Christensen JF. The effects of acute exercise and inflammation on immune function in early-stage prostate cancer. Brain Behav Immun Health. 2022 Sep 7;25:100508. doi: 10.1016/j.bbih.2022.100508. eCollection 2022 Nov.
PubMed 36133956
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03675529
- Acronym / sponsor ID
- SHOR-TEST / H-18020711
- Conditions
- Prostate Cancer
- Keywords
- prostate neoplasm, exercise, high intensity interval training, tumor hypoxia, immune cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Nov 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and purpose: The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer undergoing radical prostatectomy.
The primary hypothesis is that exercise reduces tumor hypoxia and that the reduction is greater in patients performing one acute high intensity exercise bout compared to no training controls.
The investigators have not been able to identify any prior or current randomized trials investigating exercise and tumor hypoxia, and believe that such research is warranted and would be of great importance. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.
Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.
Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either one single acute High Intensity Interval Training bout or usual care and no training the day prior to radical prostatectomy.
All patients will undergo assessment at inclusion (baseline) and the day prior to surgery.
Assessment includes: anthropometrics; blood pressure; resting hearth rate; hip and waist circumference, ECG, quality of life by self-report questionnaires; fasting blood sample measuring PSA (prostate specific antigen), cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose and inflammatory markers.
All patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate.
Biological tissue from tumor (primary prostate biopsies) will also be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.
Detailed description
The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer randomized to one single acute I) High Intensity Interval Training bout compared to (II) usual care and no training prior to radical prostatectomy.
In addition to this the aim is to investigate the effect of one exercise bout on tumor vessel morphology and to investigate the effect of one acute exercise bout on intratumoral immune cell infiltration and to investigate the modulation of tumor-metabolism, -biology and signaling in patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.
Moreover this study will explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session, and will collect physiological (metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) information regarding patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training bout | Experimental | Behavioral: High Intensity Interval Training boutPatients randomized to this group will perform a wattmax test immediately followed by 4 intervals of high and low intensity based on percentage of wattmax. Immediately after the exercise bout is finished patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day. |
| Controls (usual care) | No intervention | –Patients randomized to the control group will not be doing any exercise, but will after approximately 35 min from baseline blood sampling receive one dose of pimonidazole hydrochloride (500 mg per m2 bodysurface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with histologically verified localized prostate adenocarcinoma undergoing curative intended radical prostatectomy.
Key exclusion criteria (7 listed)
- Age: <18 years
- Any other known malignancy requiring active treatment
- Performance status > 1
- Allergy to pimonidazole
- Ongoing treatment with beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training boutPatients randomized to the HIIT bout will perform one single supervised High Intensity Interval Training bout consisting firstly of a wattmax test on a stationary bike, in order to set the training intensity. This is followed by 10 minutes at low intensity at approximately 30% of wattmax. Subsequently patients will perform 16 min with 4 cycles with High and Low intensity. HI intervals consisting of 1 min with 100% of wattmax followed by 3 min recovery with the intensity load of 30% of wattmax. | Behavioural | High Intensity Interval Training bout |
Primary outcome
Tumor hypoxia
Time frame: At prostatectomy
Quantification of tumor hypoxia will be assessed using pimonidazole staining
18 secondary outcomes
Intratumoral immune cell infiltration
Time frame: Primary prostate biopsies and until radical prostatectomy
Tumor vessel morphology
Time frame: Primary prostate biopsies and until radical prostatectomy
Tumor metabolism-, biology and signaling
Time frame: Primary prostate biopsies and until radical prostatectomy
Changes in immune cells during an acute exercise bout
Time frame: From start of exercise bout and until 60 minutes post exercise
Changes in epinephrine concentration
Time frame: From start of exercise bout and until 60 minutes post exercise
Changes in nor-epinephrine concentration
Time frame: From start of exercise bout and until 60 minutes post exercise
Changes in various interleukines
Time frame: From start of exercise bout and until 60 minutes post exercise
Changes in Tumor Necrosis Factor alpha (TNFa) concentration
Time frame: From start of exercise bout and until 60 minutes post exercise
Changes in Interferon Gamma (IFNγ) concentration
Time frame: From start of exercise bout and until 60 minutes post exercise
Concentration of C-reactive Protein (CRP)
Time frame: Blood sampling on the day of radical prostatectomy
Total plasma cholesterol concentration
Time frame: Blood sampling on the day of radical prostatectomy
Plasma LDL-Cholesterol concentration
Time frame: Blood sampling on the day of radical prostatectomy
Plasma HDL-Cholesterol concentration
Time frame: Blood sampling on the day of radical prostatectomy
Plasma triglyceride concentrations
Time frame: Blood sampling on the day of radical prostatectomy
HbA1C concentration
Time frame: Blood sampling on the day of radical prostatectomy
Plasma Insulin concentration
Time frame: Blood sampling on the day of radical prostatectomy
Plasma Glucose concentration
Time frame: Blood sampling on the day of radical prostatectomy
Wattmax-test
Time frame: At baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Derived from this study: PubMed 36199257Djurhuus SS, Schauer T, Simonsen C, Toft BG, Jensen ARD, Erler JT, Roder MA, Hojman P, Brasso K, Christensen JF. Effects of acute exercise training on tumor outcomes in men with localized prostate cancer: A randomized controlled trial. Physiol Rep. 2022 Oct;10(19):e15408. doi: 10.14814/phy2.15408.
- Derived from this study: PubMed 36133956Schauer T, Djurhuus SS, Simonsen C, Brasso K, Christensen JF. The effects of acute exercise and inflammation on immune function in early-stage prostate cancer. Brain Behav Immun Health. 2022 Sep 7;25:100508. doi: 10.1016/j.bbih.2022.100508. eCollection 2022 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sissal S Djurhuus, MD principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training bout in people with Prostate Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor hypoxia (time frame: At prostatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675529, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.