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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057274
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : March 26, 2020
Sponsor:
Collaborators:
York St John University
Newcastle University
Information provided by (Responsible Party):
Northumbria University

Tracking Information
First Submitted Date  ICMJE August 13, 2019
First Posted Date  ICMJE August 15, 2019
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE September 23, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
Cell viability (%) [ Time Frame: 24 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 24 hours. Fluorescence will then be measured using a microplate reader at an excitation of 560 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • Concentration of epinephrine (pg/ml) [ Time Frame: Immediately before and immediately after the exercise and resting assessments ]
    Systemic concentration of epinephrine will me measured from serum
  • Concentration of norepinephrine (pg/ml) [ Time Frame: Immediately before and immediately after the exercise and resting assessments ]
    Systemic concentration of norepinephrine will me measured from serum
  • Concentration of Interleukin 6 (pg/ml) [ Time Frame: Immediately before and immediately after the exercise and resting assessments ]
    Systemic concentration of Interleukin 6 will me measured from serum
  • 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 me measured from serum
  • Concentration of Insulin (pmol/l) [ Time Frame: Immediately before and immediately after the exercise and resting assessments ]
    Systemic concentration of Insulin will me measured from serum
  • 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 me measured from serum
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth
Official Title  ICMJE Effect of a Single Bout of Moderate-intensity Aerobic Exercise on Colon Cancer Cell Growth in Vitro
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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.
Primary Purpose: Prevention
Condition  ICMJE
  • Colon Adenocarcinoma
  • Colon Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Exercise assessment
  • No Intervention: Resting assessment
    The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Samuel T Orange, PhD +44 (0)191 227 3056 sam.t.orange@northumbria.ac.uk
Contact: John M Saxton, PhD + 44 (0)191 227 3371 john.saxton@northumbria.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04057274
Other Study ID Numbers  ICMJE AEROBIC2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Raw data and statistical code will be uploaded onto a publicly available repository
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: Raw data will be made available immediately after publication of the aggregated data in a peer-reviewed Journal
Access Criteria: Publicly available
Responsible Party Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE
  • York St John University
  • Newcastle University
Investigators  ICMJE
Principal Investigator: Samuel T Orange, PhD Northumbria University
PRS Account Northumbria University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP