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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Newcastle University
York St John University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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