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

August 19, 2020 updated by: Northumbria University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE1 8SG
        • Northumbria University City Campus
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO31 8FY
        • York St John University Sports Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise assessment
The exercise condition will involve venous blood samples being drawn immediately before and after a single bout of moderate-intensity aerobic interval exercise.
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.
NO_INTERVENTION: Resting assessment
The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of epinephrine (pg/ml)
Time Frame: Immediately before and immediately after the exercise and resting assessments
Systemic concentration of epinephrine will be measured from serum
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
Systemic concentration of norepinephrine will be measured from serum
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
Systemic concentration of Interleukin 6 will be measured from serum
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
Systemic concentration of Tumour Necrosis Factor alpha will be measured from serum
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
Systemic concentration of Insulin will be measured from serum
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
Systemic concentration of Insulin-like growth factor 1 will be measured from serum
Immediately before and immediately after the exercise and resting assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

Newcastle University
York St John University

Investigators

  • Principal Investigator: Samuel T Orange, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2019

Primary Completion (ACTUAL)

March 6, 2020

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (ACTUAL)

August 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEROBIC2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw data and statistical code will be uploaded onto a publicly available repository

IPD Sharing Time Frame

Raw data will be made available immediately after publication of the aggregated data in a peer-reviewed Journal

IPD Sharing Access Criteria

Publicly available

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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