NCT04057274

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

August 20, 2020

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

August 13, 2019

Last Update Submit

August 19, 2020

Conditions

Keywords

Colon cancerAerobic exercise

Outcome Measures

Primary Outcomes (1)

  • Cell viability (%)

    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 Outcomes (6)

  • Concentration of epinephrine (pg/ml)

    Immediately before and immediately after the exercise and resting assessments

  • Concentration of norepinephrine (pg/ml)

    Immediately before and immediately after the exercise and resting assessments

  • Concentration of Interleukin 6 (pg/ml)

    Immediately before and immediately after the exercise and resting assessments

  • Concentration of Tumour Necrosis Factor alpha (pg/ml)

    Immediately before and immediately after the exercise and resting assessments

  • Concentration of Insulin (pmol/l)

    Immediately before and immediately after the exercise and resting assessments

  • +1 more secondary outcomes

Study Arms (2)

Exercise assessment

EXPERIMENTAL

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

Resting assessment

NO INTERVENTION

The resting condition will involve venous blood samples being drawn before and after 60 minutes of seated rest.

Interventions

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.

Exercise assessment

Eligibility Criteria

Age50 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

York St John University Sports Park

York, North Yorkshire, YO31 8FY, United Kingdom

Location

Northumbria University City Campus

Newcastle upon Tyne, NE1 8SG, United Kingdom

Location

Related Publications (4)

  • Boyle T, Keegel T, Bull F, Heyworth J, Fritschi L. Physical activity and risks of proximal and distal colon cancers: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Oct 17;104(20):1548-61. doi: 10.1093/jnci/djs354. Epub 2012 Aug 22.

    PMID: 22914790BACKGROUND
  • Dethlefsen C, Hansen LS, Lillelund C, Andersen C, Gehl J, Christensen JF, Pedersen BK, Hojman P. Exercise-Induced Catecholamines Activate the Hippo Tumor Suppressor Pathway to Reduce Risks of Breast Cancer Development. Cancer Res. 2017 Sep 15;77(18):4894-4904. doi: 10.1158/0008-5472.CAN-16-3125.

    PMID: 28887324BACKGROUND
  • Dethlefsen C, Pedersen KS, Hojman P. Every exercise bout matters: linking systemic exercise responses to breast cancer control. Breast Cancer Res Treat. 2017 Apr;162(3):399-408. doi: 10.1007/s10549-017-4129-4. Epub 2017 Jan 30.

    PMID: 28138894BACKGROUND
  • Devin JL, Hill MM, Mourtzakis M, Quadrilatero J, Jenkins DG, Skinner TL. Acute high intensity interval exercise reduces colon cancer cell growth. J Physiol. 2019 Apr;597(8):2177-2184. doi: 10.1113/JP277648. Epub 2019 Mar 20.

    PMID: 30812059BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Samuel T Orange, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It is not possible to blind participants nor investigators. Investigators will be blind to allocation order until after the first blood sample is drawn.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is a randomised, counterbalanced, crossover study whereby all participants will complete an exercise assessment and a resting assessment in a randomised order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

September 23, 2019

Primary Completion

March 6, 2020

Study Completion

September 30, 2020

Last Updated

August 20, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, 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

Locations