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

Sponsor
Northumbria University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04057274
Collaborator
York St John University (Other), Newcastle University (Other)
16
Enrollment
2
Locations
2
Arms
12.3
Anticipated Duration (Months)
8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise assessment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 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.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 :
Sep 23, 2019
Actual Primary Completion Date :
Mar 6, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cell viability (%) [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) [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) [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) [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) [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) [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) [Immediately before and immediately after the exercise and resting assessments]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 York St John University Sports Park York North Yorkshire United Kingdom YO31 8FY
2 Northumbria University City Campus Newcastle Upon Tyne United Kingdom NE1 8SG

Sponsors and Collaborators

  • Northumbria University
  • York St John University
  • Newcastle University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Northumbria University
ClinicalTrials.gov Identifier:
NCT04057274
Other Study ID Numbers:
  • AEROBIC2019
First Posted:
Aug 15, 2019
Last Update Posted:
Aug 20, 2020
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Colonic Neoplasms

Study Results

No Results Posted as of Aug 20, 2020