NCT06911970

Brief Summary

The goal of this clinical trial is to determine to what extent anticancer immune cells mobilized by aerobic exercise exhibit migratory and functional capacity towards cancer cells in patients undergoing treatment for breast or colorectal cancer. The main questions it aims to answer are:

  • Do anticancer immune cells mobilized by aerobic exercise will display migratory and functional capacity in patients undergoing treatment for curable breast or colorectal cancer? Hypothesis: exercise will promote cell migration and these cells will display anti-cancer functional characteristics, suggesting a possible adjuvant and immunotherapeutic use of exercise.
  • Do the magnitude of this anti-cancer immune response to exercise depend on the intensity of exercise? Hypothesis: the achievement of a higher intensity of effort will enable greater mobilization of the cytotoxic lymphocytes of interest, but also the expression of markers predicting a more interesting adjuvant potential to immunotherapy. Researchers will compare the effect of two exercise sessions, one moderate-intensity continuous exercise session (MOD) and one high-intensity interval exercise (HIIE) on the migration and anticancer potentials of mobilized immune cells. Individuals aged between 40 and 70 with curable colon or breast cancer will be recruited to carry out a cross-over study with two experimental conditions. After a preliminary assessment visit, they will take part in:
  • Two familiarization visits to validate the exercise prescription
  • Two experimental visits (HIIE and MOD). During these conditions, blood samples will be taken before, after and 1 hour after the end of exercise to collect immune cells in the blood. At the end of the visits, participants will leave with an accelerometer to wear for three days depending on conditions, and a notebook containing a questionnaire to assess fatigue levels over the same three days.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
17mo left

Started Apr 2025

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress44%
Apr 2025Sep 2027

First Submitted

Initial submission to the registry

March 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 29, 2025

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

March 28, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

cancerexerciseT cellsNK cellsMigrationtreatmentcytotoxicimmunology

Outcome Measures

Primary Outcomes (2)

  • Change in migratory capacity of different peripheral blood mononuclear cells (Natural Killer Cells and T cells)

    Transwell migration assay

    Before the start of the condition (t = 0 minute), at the end of the condition (t ≈ 35 minutes), 1 hour post-condition (t ≈ 95 minutes)

  • Change in the concentration and characterization of subpopulations of migrated peripheral blood mononuclear cells

    Flow cytometry

    Before the start of the condition (t = 0 minute), at the end of the condition (t ≈ 35 minutes), 1 hour post-condition (t ≈ 95 minutes)

Secondary Outcomes (4)

  • Change in the concentration of inflammatory mediators in peripheral blood (chemokines, pro- and anti-inflammatory cytokines)

    Before the start of the condition (t = 0 minute), at the end of the condition (t ≈ 35 minutes), 1 hour post-condition (t ≈ 95 minutes)

  • Change in catecholamines concentrations

    Before the start of the condition (t = 0 minute), at the end of the condition (t ≈ 35 minutes), 1 hour post-condition (t ≈ 95 minutes)

  • Cancer-Related Fatigue

    During 3 days after the conditions.

  • Changes in physical activity levels

    During 3 days after the conditions

Study Arms (2)

Condition HIIE

EXPERIMENTAL

Individuals undergoing cancer treatment will complete one session of high-intensity interval exercise (HIIE) with a ratio high-intensity/active recovery of 1 min /2 min. During the condition blood samples will be collected.

Other: Exercise

Condition MOD

ACTIVE COMPARATOR

Individuals undergoing cancer treatment will complete one moderate-intensity continuous exercise (MOD) session during which blood samples will be collected. MOD will consist of aerobic exercise that match external workload of HIIE.

Other: Exercise

Interventions

Moderate-Intensity Continuous Exercise (MOD): The MOD condition will consist of a 37-minute continuous aerobic exercise session on ergocycle. This includes a warm-up and cool-down period at low intensity, and a 32-minute period at moderate intensity at a power corresponding to 50% of the last stop completed in the modified YMCA test completed in the preliminary visit. High-Intensity Interval Exercise (HIIE): The HIIE condition will consist of a 35-minute high-intensity aerobic exercise session on ergocycle. This includes a warm-up at low intensity, followed by 10 blocks of 1 minute at high intensity (110% of power highest poweroutput reached during the submaximal test) and 2 minutes of active rest (25% of highest power output).

Condition HIIECondition MOD

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of non-metastatic breast or colon cancer
  • Age between 40 and 70
  • Have started chemotherapy or immunotherapy treatment and have at least three treatments remaining in the cycle
  • ECOG stage 0 to 1
  • Be able to perform moderate-intensity aerobic exercise (MOD) or EPI type cycling according to the established prescription and without experiencing pain in connection with the bicycle saddle

You may not qualify if:

  • Orthopedic, cardiac or metabolic limitation preventing safe aerobic exercise
  • Non-controlled health condition
  • Use of beta-blockers
  • Planned surgery during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Center on Aging

Sherbrooke, Quebec, J1H 2J7, Canada

RECRUITING

Research Center on Aging

Sherbrooke, Quebec, J1H 4C4, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsNeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eléonor Riesco, PhD

    University of Sherbrooke, Faculty of Physical Activity Sciences, Department of Kinanthropology

    PRINCIPAL INVESTIGATOR
  • Lee-Hwa Tai, PhD

    University of Sherbrooke, Faculty of Medicine and Health Sciences, Department of Immunology and Cellular Biology

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Each participant performed 2 experimental conditions (moderate continuous exercise and high-intensity interval exercise).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

August 29, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations