CClinicalTrials.gg
RecruitingNCT06911970Immuno-ExUpdated Aug 29, 2025

Impact of Aerobic Exercise on the Anticancer Immune Response in Patients Receiving Cancer Treatment

An interventional study of Exercise in Colorectal Cancer, Breast Cancer and Non Metastatic Cancer, sponsored by Université de Sherbrooke. Recruiting at 2 sites in Canada. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

In recent years, there has been growing interest in the therapeutic role of exercise in the context of oncology. Several murine models have demonstrated a reduction in tumor growth with aerobic exercise, which is partly due to the increased immunogenicity of the tumor microenvironment (TME). Aerobic exercise has the potential to mobilize cytotoxic immune cells, particularly those contributing to anticancer immunity (natural killer cells; NKc, and cytotoxic T lymphocytes; TCD8+), both in healthy individuals and in those living with cancer. In the latter, a session of aerobic exercise induces a transient rise in plasma lymphocytes, followed by their extravasation into inflamed tissues in the hours following exercise. This phenomenon, known as "exercise-immune-enhancement," appears to be heavily dependent on the adrenergic activation triggered by exercise. In other words, NKc and TCD8+ cells are mobilized in response to exercise of sufficient intensity, meaning a minimal physiological threshold must be reached during physical exertion, which should be identified on an individual basis (i.e., the second lactate threshold). However, it is crucial that cytotoxic immune cells mobilized by aerobic exercise can infiltrate the TME and exhibit characteristics that allow them to counter immune evasion mechanisms. Animal studies have shown that aerobic training increases the number of NKc and TCD8+ cells within primary tumors and delays tumor growth, supporting the hypothesis that exercise could stimulate tumor infiltration by cytotoxic lymphocytes acting within the TME. To date, no human studies conducted during treatment have confirmed this hypothesis.

The main objective of this study is to determine to what extent Tc and NK cells mobilized by aerobic exercise will exhibit migratory and functional capacity in patients undergoing treatment for curable breast or colorectal cancer. The secondary objective is to compare the effect of a moderate-intensity exercise (MOD) session with an high-intensity interval exercise (HIIE) session on the magnitude of this anti-cancer immune response to exercise and on the phenotypic and functional characteristics of the cells that have been mobilized.

The hypothesis is that exercise will promote cell migration, enhancing anti-cancer functionality, suggesting its potential as an adjuvant to immunotherapy. Additionally, higher exercise intensity is expected to increase mobilization of cytotoxic lymphocytes and expression of markers indicating stronger immunotherapeutic potential.

Forty-four individuals (aged 40-70) undergoing adjuvant treatment for breast or colorectal cancer will be recruited to participate in a randomized, crossover study with variable block size and counterbalanced design comparing the effect of two exercise modalities (MOD and HIIE), on the migratory and functional capacity of cytotoxic immune cells. An initial visit will be conducted to collect the following variables: resting heart rate and blood pressure, anthropometry, medical history, physical activity habits (questionnaire), gender identity, and aerobic capacity, which will be assessed using a submaximal graded exercise test on a cycle ergometer (modified YMCA). During MOD, participants will complete 32 minutes of cycling at 50% of the power output achieved during the last completed stage of the submaximal test. During the HIIE condition, participants will complete 10 intervals alternating 1 minute of intense effort at a power corresponding to 110% of the final stage completed in the modified YMCA test and 2 minutes of active recovery at 25% of the same stage, for a total duration of 30 minutes. Both experimental conditions are thus equivalent in terms of external effort load. During both exercise sessions, blood samples will be collected before, immediately after exercise cessation, and at 60 and 120 minutes post-exercise for complete blood counts and isolation of peripheral blood mononuclear cells (PBMCs) to assess migratory and functional capacity. Two familiarization sessions will precede the experimental conditions to test the respective prescriptions for MOD and HIIE to ensure that participants can complete the sessions at the required intensity to meet the research objective. A chemotactic gradient migration assay (Transwell assay) will be performed using the thawed PBMCs, and those that have migrated after 4 hours will be collected to characterize NKc and TCD8+ subpopulations and assess cytotoxicity potential using surface and intracellular antibody staining (fluorescence-activated cell sorting [FACS]).

The results of this study will help determine the extent to which the TCD8+ and NKc mobilized by aerobic exercise can migrate towards cancer cells, as well as the characteristics associated with anticancer cytotoxicity in individuals undergoing systemic treatment for curable breast or colorectal cancer. This data will help guide larger-scale randomized clinical studies with control groups aimed at confirming the adjuvant therapeutic role of individualized aerobic exercise in individuals undergoing systemic treatment.

02

Conditions studied

  • Colorectal Cancer
  • Breast Cancer
  • Non Metastatic Cancer

Keywords

  • cancer
  • exercise
  • T cells
  • NK cells
  • Migration
  • treatment
  • cytotoxic
  • immunology
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 44 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Orthopedic, cardiac or metabolic limitation preventing safe aerobic exercise
  • Non-controlled health condition
  • Use of beta-blockers
  • Planned surgery during the study period.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Condition HIIE

    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

  • Active comparator
    Condition MOD

    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

  • OtherExercise

    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).

06

What researchers measure

Primary outcomes

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

    Transwell migration assay

    Time frame: 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)

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

    Flow cytometry

    Time frame: 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

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

    Multiplex immunoassay

    Time frame: 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)

  2. Change in catecholamines concentrations

    ELISA Kits

    Time frame: 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)

  3. Cancer-Related Fatigue

    Multidimensional Fatigue Inventory 20 (MFI-20)

    Time frame: During 3 days after the conditions.

  4. Changes in physical activity levels

    Actigraph GT3X accelerometer

    Time frame: During 3 days after the conditions

07

Study locations

1 of 2 sites recruiting
  • Research Center on Aging
    Sherbrooke, Quebec J1H 2J7, Canada
    Recruiting
  • Research Center on Aging
    Sherbrooke, Quebec J1H 4C4, Canada
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06911970
Lead sponsor
Université de Sherbrooke
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Apr 1, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 29, 2025

Study contacts

Eléonor Riesco, PhD
Contact
eleonor.riesco@usherbrooke.ca
819-821-8000 ext. 63337
Laurence Poirier, MSc
Contact
laurence.poirier2@usherbrooke.ca
819-780-2220 ext. 45312
Eléonor Riesco, PhD
principal investigator · University of Sherbrooke, Faculty of Physical Activity Sciences, Department of Kinanthropology
Lee-Hwa Tai, PhD
study director · University of Sherbrooke, Faculty of Medicine and Health Sciences, Department of Immunology and Cellular Biology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion