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Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth (AEROBIC)

Primary Purpose

Colon Adenocarcinoma, Colon Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Exercise assessment

About this trial

This is an interventional prevention trial for Colon Adenocarcinoma focused on measuring Colon cancer, Aerobic exercise

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

York St John University Sports Park
Northumbria University City Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise assessment

Resting assessment

Arm Description

The exercise condition will involve venous blood samples being drawn immediately before and after a single bout of moderate-intensity aerobic interval exercise.

The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Concentration of epinephrine (pg/ml)

Systemic concentration of epinephrine will be measured from serum

Concentration of norepinephrine (pg/ml)

Systemic concentration of norepinephrine will be measured from serum

Concentration of Interleukin 6 (pg/ml)

Systemic concentration of Interleukin 6 will be measured from serum

Concentration of Tumour Necrosis Factor alpha (pg/ml)

Systemic concentration of Tumour Necrosis Factor alpha will be measured from serum

Concentration of Insulin (pmol/l)

Systemic concentration of Insulin will be measured from serum

Concentration of Insulin-like growth factor 1 (ng/ml)

Systemic concentration of Insulin-like growth factor 1 will be measured from serum

Full Information

NCT ID

NCT04057274

First Posted

August 13, 2019

Last Updated

August 19, 2020

Sponsor

Northumbria University

Collaborators

York St John University, Newcastle University

1. Study Identification

Unique Protocol Identification Number

NCT04057274

Brief Title

Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth

Acronym

AEROBIC

Official Title

Effect of a Single Bout of Moderate-intensity Aerobic Exercise on Colon Cancer Cell Growth in Vitro

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 23, 2019 (Actual)

Primary Completion Date

March 6, 2020 (Actual)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northumbria University

Collaborators

York St John University, Newcastle University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Adenocarcinoma, Colon Cancer

Keywords

Colon cancer, Aerobic exercise

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Masking Description

It is not possible to blind participants nor investigators. Investigators will be blind to allocation order until after the first blood sample is drawn.

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise assessment

Arm Type

Experimental

Arm Description

The exercise condition will involve venous blood samples being drawn immediately before and after a single bout of moderate-intensity aerobic interval exercise.

Arm Title

Resting assessment

Arm Type

No Intervention

Arm Description

The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest.

Intervention Type

Other

Intervention Name(s)

Exercise assessment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cell viability (%)

Description

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Concentration of epinephrine (pg/ml)

Description

Systemic concentration of epinephrine will be measured from serum

Time Frame