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Colorectal CancerImmuno-ExNCT06911970

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

A study testing Exercise in people with Colorectal Cancer and Breast Cancer, run by Université de Sherbrooke at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesCanada
Study dates
1 Apr 2025to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada2 sites, 2 recruiting
  • Research Center on Aging

    Sherbrooke, Quebec, J1H 2J7

    Eléonor Riesco, PhD, 1 819 821-8000 ext. 63337, e.riesco@usherbrooke.ca

    Laurence Poirier, M.Sc., 819-780-2220 ext. 45312, laurence.poirier2@usherbrooke.ca

    Recruiting
  • Research Center on Aging

    Sherbrooke, Quebec, J1H 4C4

    Hugo Parent-Roberge, PhD, 8198-821-8000, hugo.parent-roberge@usherbrooke.ca

    Eléonor Riesco, PhD

    Not yet recruiting

Other trials in Canada

About this study

Official title: Acute Effect of Moderate and High-Intensity Aerobic Exercise on the Anticancer Immune Response in Individuals Undergoing Treatment for Curable Cancer

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?
Read more

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.

Being tested
Exercise
Keywords
cancer, exercise, T cells, NK cells, Migration, treatment, cytotoxic, immunology
Medical subject headings
Colorectal Neoplasms, Breast Neoplasms, Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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).

Study groups in NCT06911970
Study groupRoleWhat they receive
Condition HIIEExperimentalIndividuals 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.
Receives: Other: Exercise
Condition MODActive comparatorIndividuals 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Transwell migration assay

    Measured: 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

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

    Multiplex immunoassay

    Measured: 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

    Measured: 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)

    Measured: During 3 days after the conditions.

  4. Changes in physical activity levels

    Actigraph GT3X accelerometer

    Measured: During 3 days after the conditions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Apr 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Each participant performed 2 experimental conditions (moderate continuous exercise and high-intensity interval exercise).
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911970
Sponsor's protocol ID
2025-5606
Acronym
Immuno-Ex
Status last verified
Oct 2024
First submitted
28 Mar 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Colorectal Cancer and Breast Cancer, run by Université de Sherbrooke at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eléonor Riesco, PhD (819-821-8000 ext. 63337, eleonor.riesco@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in migratory capacity of different peripheral blood mononuclear cells (Natural Killer Cells and T cells) (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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