Recruiting

Aerobic Exercise

Sponsor:

Université de Sherbrooke

Code:

NCT06911970

Conditions

Colorectal Cancer

Breast Cancer

Non Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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.

Conditions

Colorectal Cancer

Breast Cancer

Non Metastatic Cancer

Study ID

NCT06911970

Start date

Apr 1, 2025

Status verified date

Oct, 2024

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

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.

Interventions

Exercise

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).

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

Central Contacts and Locations

Locations

Research Center on Aging

Recruiting

Sherbrooke, Quebec, Canada, J1H 2J7

Contacts

Principal Investigator:

Eléonor Riesco, PhD

More Information

Sponsor

Université de Sherbrooke

Last update posted

Aug 29, 2025

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-08-29.