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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

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.


Condition or disease Intervention/treatment Phase
Colon Adenocarcinoma Colon Cancer Other: Exercise assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Official Title: Effect of a Single Bout of Moderate-intensity Aerobic Exercise on Colon Cancer Cell Growth in Vitro
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057274


Contacts
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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

Locations
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United Kingdom
York St John University Sports Park Recruiting
York, North Yorkshire, United Kingdom, YO31 8FY
Contact: Alastair Jordan, PhD    01904 876125    a.jordan1@yorksj.ac.uk   
Northumbria University City Campus Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 8SG
Contact: Samuel Orange, PhD    01912273056    sam.t.orange@northumbria.ac.uk   
Sponsors and Collaborators
Northumbria University
York St John University
Newcastle University
Investigators
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Principal Investigator: Samuel T Orange, PhD Northumbria University
Publications:
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT04057274    
Other Study ID Numbers: AEROBIC2019
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw data and statistical code will be uploaded onto a publicly available repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
Colon cancer
Aerobic exercise
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases