Colon AdenocarcinomaAEROBICNCT04057274
Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth
A study testing Exercise assessment in people with Colon Adenocarcinoma and Colon Cancer, run by Northumbria University at 2 sites in United Kingdom.
Trial summary
This study involves drawing blood samples from men before and after they perform 30-minutes of moderate-intensity aerobic exercise. The investigators will evaluate whether adding the exercise serum to colon cancer cells in a dish can reduce the growth of the cells compared to the resting serum. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colon Adenocarcinoma, Colon Cancer
- What is being tested?
- Exercise assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Sep 2019to 30 Sep 2020
- 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 50 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- BMI ≥ 25 kg/m2 and/or waist circumference of ≥ 94 cm
- Male
- Participating in less than 30 min of planned, structured, moderate to vigorous-intensity physical activity on three or more d·wk-1 for the last three months
Who cannot join
- Any absolute or relative contraindication to exercise testing, as determined by the American College of Sports Medicine
- Any sign/symptom of cardiovascular, metabolic or renal disease
- Known cardiovascular, metabolic or renal disease without written medical clearance from physician
- Resting hypertension (≥160 mmHg systolic and/or ≥90 mmHg diastolic)
- Chronic obstructive pulmonary disease and/or asthma with peak respiratory flow < 300 l/min
- Previous stroke or transient ischemic attack
Show all 13Show fewer
- Epilepsy or aneurysm (large vessel or cerebral)
- Previous or current treatment for malignancy
- Clotting disorder
- Taking beta-adrenergic blocking agents
- Resting heart rate ≥ 100 bpm
- Musculoskeletal, neurological, anthropometric, or rheumatoid conditions that makes it not possible to pedal a bicycle and/or would be worsened due to exercise
- Body mass > 150 kg
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Northumbria University City Campus
Newcastle upon Tyne, NE1 8SG
York St John University Sports Park
York, North Yorkshire, YO31 8FY
About this study
Official title: Effect of a Single Bout of Moderate-intensity Aerobic Exercise on Colon Cancer Cell Growth in Vitro
This study involves drawing blood samples from men before and after they perform 30-minutes of moderate-intensity aerobic exercise. The investigators will evaluate whether adding the exercise serum to colon cancer cells in a dish can reduce the growth of the cells compared to the resting serum.
Note: serum is the liquid part of the blood that carries hormones and metabolites around the body.
Read the detailed description
Regular exercise is associated with a reduced risk of developing colon cancer. However, the mechanisms underpinning the anti-cancer effect of exercise are not yet fully understood. A recent theory suggests that each time you exercise, the short-lasting spikes in circulating hormones can suppress the growth of cancer cells. Hence, every exercise bout could have a direct anti-cancer effect.
This study will recruit men with an increased of colon cancer and explore whether incubating colon cancer cells with serum collected after a bout of moderate-intensity aerobic exercise influences cell viability in vitro.
- Conditions
- Colon Adenocarcinoma, Colon Cancer
- Being tested
- Exercise assessment
- Keywords
- Colon cancer, Aerobic exercise
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise assessmentOther
The moderate-intensity aerobic interval exercise will be performed on a cycle ergometer under the supervision of trained staff in an exercise science laboratory. Participants will perform a 5 to 10-minute warm-up that begins by pedalling against a light resistance (60 W) and progressively increases in resistance until a target heart rate of 50-60% heart rate reserve is achieved. Participants will then complete 6 x 5-minute bouts at 60% heart rate reserve whilst maintaining a cadence of 60 rev·min-1, separated by 2.5-minutes of pedalling against light resistance (60 W). The session will finish with a cool-down at light resistance (60 W) lasting 10-minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise assessment | Experimental | The exercise condition will involve venous blood samples being drawn immediately before and after a single bout of moderate-intensity aerobic interval exercise. Receives: Other: Exercise assessment |
| Resting assessment | No intervention | The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell viability (%)
Viability of a human colon cancer cell line (LoVo) will be assessed via quantification of the fluorescent signal by the resazurin assay (Sigma-Aldrich, Dorset, UK). Cells will be seeded in culture medium containing 10% serum from individual participants and incubated for 48 hours. Fluorescence will then be measured using a microplate reader at an excitation of 540 nm and emission of 590 nm. Background fluorescence will be subtracted from each well and then values will be normalised to fluorescence of control cells grown in 10% fetal bovine serum instead of participant serum to give a percent viability.
Measured: 48 hours
Secondary outcomes (6)
Concentration of epinephrine (pg/ml)
Systemic concentration of epinephrine will be measured from serum
Measured: Immediately before and immediately after the exercise and resting assessments
Concentration of norepinephrine (pg/ml)
Systemic concentration of norepinephrine will be measured from serum
Measured: Immediately before and immediately after the exercise and resting assessments
Concentration of Interleukin 6 (pg/ml)
Systemic concentration of Interleukin 6 will be measured from serum
Measured: Immediately before and immediately after the exercise and resting assessments
Concentration of Tumour Necrosis Factor alpha (pg/ml)
Systemic concentration of Tumour Necrosis Factor alpha will be measured from serum
Measured: Immediately before and immediately after the exercise and resting assessments
Concentration of Insulin (pmol/l)
Systemic concentration of Insulin will be measured from serum
Measured: Immediately before and immediately after the exercise and resting assessments
Concentration of Insulin-like growth factor 1 (ng/ml)
Systemic concentration of Insulin-like growth factor 1 will be measured from serum
Measured: Immediately before and immediately after the exercise and resting assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start23 Sep 2019
- Primary completion6 Mar 2020
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomised, counterbalanced, crossover study whereby all participants will complete an exercise assessment and a resting assessment in a randomised order.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- York St John University, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Samuel T Orange, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057274
- Sponsor's protocol ID
- AEROBIC2019
- Acronym
- AEROBIC
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2019
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data and statistical code will be uploaded onto a publicly available repository
Publications
Boyle T, Keegel T, Bull F, Heyworth J, Fritschi L. Physical activity and risks of proximal and distal colon cancers: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Oct 17;104(20):1548-61. doi: 10.1093/jnci/djs354. Epub 2012 Aug 22.
PubMed 22914790Dethlefsen C, Hansen LS, Lillelund C, Andersen C, Gehl J, Christensen JF, Pedersen BK, Hojman P. Exercise-Induced Catecholamines Activate the Hippo Tumor Suppressor Pathway to Reduce Risks of Breast Cancer Development. Cancer Res. 2017 Sep 15;77(18):4894-4904. doi: 10.1158/0008-5472.CAN-16-3125.
PubMed 28887324Dethlefsen C, Pedersen KS, Hojman P. Every exercise bout matters: linking systemic exercise responses to breast cancer control. Breast Cancer Res Treat. 2017 Apr;162(3):399-408. doi: 10.1007/s10549-017-4129-4. Epub 2017 Jan 30.
PubMed 28138894Devin JL, Hill MM, Mourtzakis M, Quadrilatero J, Jenkins DG, Skinner TL. Acute high intensity interval exercise reduces colon cancer cell growth. J Physiol. 2019 Apr;597(8):2177-2184. doi: 10.1113/JP277648. Epub 2019 Mar 20.
PubMed 30812059
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Bout of Moderate-intensity Aerobic Exercise on Colon Cancer Cell Growth in Vitro
- ClinicalTrials.gov ID
- NCT04057274
- Acronym / sponsor ID
- AEROBIC / AEROBIC2019
- Conditions
- Colon Adenocarcinoma, Colon Cancer
- Keywords
- Colon cancer, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- York St John University, Newcastle University
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 15 Aug 2019 (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.
This study involves drawing blood samples from men before and after they perform 30-minutes of moderate-intensity aerobic exercise. The investigators will evaluate whether adding the exercise serum to colon cancer cells in a dish can reduce the growth of the cells compared to the resting serum.
Note: serum is the liquid part of the blood that carries hormones and metabolites around the body.
Detailed description
Regular exercise is associated with a reduced risk of developing colon cancer. However, the mechanisms underpinning the anti-cancer effect of exercise are not yet fully understood. A recent theory suggests that each time you exercise, the short-lasting spikes in circulating hormones can suppress the growth of cancer cells. Hence, every exercise bout could have a direct anti-cancer effect.
This study will recruit men with an increased of colon cancer and explore whether incubating colon cancer cells with serum collected after a bout of moderate-intensity aerobic exercise influences cell viability in vitro.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised, counterbalanced, crossover study whereby all participants will complete an exercise assessment and a resting assessment in a randomised order.
| Arm | Type | Receives |
|---|---|---|
| Exercise assessment | Experimental | Other: Exercise assessmentThe exercise condition will involve venous blood samples being drawn immediately before and after a single bout of moderate-intensity aerobic interval exercise. |
| Resting assessment | No intervention | –The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years
- BMI ≥ 25 kg/m2 and/or waist circumference of ≥ 94 cm
- Male
- Participating in less than 30 min of planned, structured, moderate to vigorous-intensity physical activity on three or more d·wk-1 for the last three months
Key exclusion criteria (13 listed)
- Any absolute or relative contraindication to exercise testing, as determined by the American College of Sports Medicine
- Any sign/symptom of cardiovascular, metabolic or renal disease
- Known cardiovascular, metabolic or renal disease without written medical clearance from physician
- Resting hypertension (≥160 mmHg systolic and/or ≥90 mmHg diastolic)
- Chronic obstructive pulmonary disease and/or asthma with peak respiratory flow < 300 l/min
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 |
|---|---|---|
| Exercise assessmentThe moderate-intensity aerobic interval exercise will be performed on a cycle ergometer under the supervision of trained staff in an exercise science laboratory. Participants will perform a 5 to 10-minute warm-up that begins by pedalling against a light resistance (60 W) and progressively increases in resistance until a target heart rate of 50-60% heart rate reserve is achieved. Participants will then complete 6 x 5-minute bouts at 60% heart rate reserve whilst maintaining a cadence of 60 rev·min-1, separated by 2.5-minutes of pedalling against light resistance (60 W). The session will finish with a cool-down at light resistance (60 W) lasting 10-minutes. | Other | Exercise assessment |
Primary outcome
Cell viability (%)
Time frame: 48 hours
Viability of a human colon cancer cell line (LoVo) will be assessed via quantification of the fluorescent signal by the resazurin assay (Sigma-Aldrich, Dorset, UK). Cells will be seeded in culture medium containing 10% serum from individual participants and incubated for 48 hours. Fluorescence will then be measured using a microplate reader at an excitation of 540 nm and emission of 590 nm. Background fluorescence will be subtracted from each well and then values will be normalised to fluorescence of control cells grown in 10% fetal bovine serum instead of participant serum to give a percent viability.
6 secondary outcomes
Concentration of epinephrine (pg/ml)
Time frame: Immediately before and immediately after the exercise and resting assessments
Concentration of norepinephrine (pg/ml)
Time frame: Immediately before and immediately after the exercise and resting assessments
Concentration of Interleukin 6 (pg/ml)
Time frame: Immediately before and immediately after the exercise and resting assessments
Concentration of Tumour Necrosis Factor alpha (pg/ml)
Time frame: Immediately before and immediately after the exercise and resting assessments
Concentration of Insulin (pmol/l)
Time frame: Immediately before and immediately after the exercise and resting assessments
Concentration of Insulin-like growth factor 1 (ng/ml)
Time frame: Immediately before and immediately after the exercise and resting assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Background: PubMed 22914790Boyle T, Keegel T, Bull F, Heyworth J, Fritschi L. Physical activity and risks of proximal and distal colon cancers: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Oct 17;104(20):1548-61. doi: 10.1093/jnci/djs354. Epub 2012 Aug 22.
- Background: PubMed 28887324Dethlefsen C, Hansen LS, Lillelund C, Andersen C, Gehl J, Christensen JF, Pedersen BK, Hojman P. Exercise-Induced Catecholamines Activate the Hippo Tumor Suppressor Pathway to Reduce Risks of Breast Cancer Development. Cancer Res. 2017 Sep 15;77(18):4894-4904. doi: 10.1158/0008-5472.CAN-16-3125.
- Background: PubMed 28138894Dethlefsen C, Pedersen KS, Hojman P. Every exercise bout matters: linking systemic exercise responses to breast cancer control. Breast Cancer Res Treat. 2017 Apr;162(3):399-408. doi: 10.1007/s10549-017-4129-4. Epub 2017 Jan 30.
- Background: PubMed 30812059Devin JL, Hill MM, Mourtzakis M, Quadrilatero J, Jenkins DG, Skinner TL. Acute high intensity interval exercise reduces colon cancer cell growth. J Physiol. 2019 Apr;597(8):2177-2184. doi: 10.1113/JP277648. Epub 2019 Mar 20.
- Individual participant dataSharing planned: Yes. Raw data and statistical code will be uploaded onto a publicly available repository
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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.
Samuel T Orange, PhD principal investigator
Northumbria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise assessment in people with Colon Adenocarcinoma and Colon Cancer, run by Northumbria University at 2 sites in United Kingdom.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
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?
Cell viability (%) (time frame: 48 hours). 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 NCT04057274, which also lists 4 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 20 Aug 2020.