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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04057274
Other study ID # AEROBIC2019
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 23, 2019
Est. completion date September 30, 2020

Study information

Verified date September 2019
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Note: serum is the liquid part of the blood that carries hormones and metabolites around the body.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date September 30, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise assessment
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.

Locations

Country Name City State
United Kingdom Northumbria University City Campus Newcastle Upon Tyne
United Kingdom York St John University Sports Park York North Yorkshire

Sponsors (3)

Lead Sponsor Collaborator
Northumbria University Newcastle University, York St John University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. Review. — View Citation

Dethlefsen 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. — View Citation

Dethlefsen 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. Review. — View Citation

Devin 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 48 hours
Secondary Concentration of epinephrine (pg/ml) Systemic concentration of epinephrine will be measured from serum Immediately before and immediately after the exercise and resting assessments
Secondary Concentration of norepinephrine (pg/ml) Systemic concentration of norepinephrine will be measured from serum Immediately before and immediately after the exercise and resting assessments
Secondary Concentration of Interleukin 6 (pg/ml) Systemic concentration of Interleukin 6 will be measured from serum Immediately before and immediately after the exercise and resting assessments
Secondary Concentration of Tumour Necrosis Factor alpha (pg/ml) Systemic concentration of Tumour Necrosis Factor alpha will be measured from serum Immediately before and immediately after the exercise and resting assessments
Secondary Concentration of Insulin (pmol/l) Systemic concentration of Insulin will be measured from serum Immediately before and immediately after the exercise and resting assessments
Secondary Concentration of Insulin-like growth factor 1 (ng/ml) Systemic concentration of Insulin-like growth factor 1 will be measured from serum Immediately before and immediately after the exercise and resting assessments
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