Effect of moderate physical exercise on the immune system in patients with breast cancer receiving preoperative chemotherapy
| ISRCTN | ISRCTN10851800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10851800 |
| Sponsor | Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo |
| Funder | Azienda Ospedaliera S. Croce e Carle di Cuneo |
- Submission date
- 20/05/2026
- Registration date
- 17/06/2026
- Last edited
- 17/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer patients who receive chemotherapy before surgery may have changes in how their immune system works. Moderate physical activity is thought to support the immune system, but it is not yet clear how this works during cancer treatment. This study aims to find out whether taking part in regular moderate exercise can change immune system activity in patients receiving chemotherapy before surgery. The researchers will look at changes in immune cells and proteins in the blood and explore how these relate to treatment and recovery.
Who can participate?
Participants are women aged 18 years or older with breast cancer who are suitable for chemotherapy before surgery and who are able to give written informed consent. People who are not suitable for preoperative chemotherapy or who cannot provide consent cannot take part.
What does the study involve?
Participants continue to receive their usual cancer care. In addition, they take part in a programme of moderate physical activity, such as Nordic walking, during the weeks before surgery. This involves around three sessions per week, each lasting about 60 minutes, over a period of about 9 to 10 weeks. Blood samples are taken at several time points before, during and after treatment and surgery to measure changes in the immune system. These include samples taken before chemotherapy, before starting exercise, just before surgery, shortly after surgery, and about 6 months after treatment.
What are the possible benefits and risks of participating?
Taking part in moderate exercise may help support general health and could improve how the immune system responds during treatment, although this is not guaranteed. The information collected may help improve understanding of how exercise affects cancer treatment in the future. Possible risks include tiredness or minor discomfort from exercise and brief discomfort or bruising from blood samples.
Where is the study run from?
The study is run from hospital centres in Italy, with coordination by Azienda Ospedaliera S. Croce e Carle di Cuneo.
When is the study starting and how long is it expected to run for?
July 2019 to February 2024.
Who is funding the study?
Azienda Ospedaliera S. Croce e Carle di Cuneo (Italy)
Who is the main contact?
Dr Ornella Garrone, ornella.garrone@gmail.com
Contact information
Principal investigator, Scientific, Public
via f. sforza 28
Milano
20122
Italy
 ORCID ID |
0000-0001-7359-5410 |
|---|---|
| Phone | 0255032660 |
| ornella.garrone@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Basic science, Translational study evaluating immune modulation induced by moderate physical activity during neoadjuvant chemotherapy in breast cancer patients. |
| Participant information sheet | 49566 PIS Informativa e Modulo CI_NEORUNNER_Milano.pdf |
| Scientific title | NEO-RUNNER: a multicentre, non-profit, interventional, non-drug translational study evaluating the effect of moderate physical exercise on cellular and cytokine immune profiles in patients with operable breast cancer receiving neoadjuvant chemotherapy |
| Study acronym | NEO-RUNNER |
| Study objectives | The NEO-RUNNER study aims to evaluate the effect of moderate physical exercise on immune system modulation in patients with operable breast cancer receiving preoperative chemotherapy. The rationale for the study is based on the hypothesis that moderate physical activity performed during neoadjuvant treatment may influence cellular and cytokine immune profiles, contributing to a better characterization of the host biological response during therapy. The study therefore aims to describe changes in prospectively collected immunological parameters, including peripheral blood samples and PBMCs, and to assess their association with patients’ clinical and treatment-related characteristics. Any additional biological analyses not specified as primary endpoints in the protocol will be considered exploratory. |
| Ethics approval(s) |
Approved 24/06/2020, Comitato Etico Interaziendale A.O. S. Croce e Carle di Cuneo – ASL CN1 – ASL CN2 – ASL AT (Via Monte Zovetto, 18, Cuneo, 12100, Italy; +39 0171 641571; comitato.etico@ospedale.cuneo.it), ref: 101-2020 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | The NEO-RUNNER study is a prospective observational study evaluating patients with operable breast cancer who are candidates for preoperative chemotherapy. Participants will perform a moderate physical exercise programme during neoadjuvant treatment. Treatment/intervention duration: 9–10 weeks of moderate physical activity through Nordic Walking in the weeks preceding surgery. The intervention includes 3 training sessions per week, each lasting approximately 60 minutes. The last training session is planned between 24 and 72 hours before surgery. Follow-up duration: study assessments include serial blood samples up to approximately 6 months after completion of chemotherapy. Overall study duration: 24 months for patient enrolment and 12 months for follow-up and data analysis, starting from Ethics Committee approval. No randomisation is planned and no placebo or control intervention is included. Physical exercise does not replace or modify standard oncological treatment, which will be decided according to routine clinical practice. Clinical, treatment-related and biological data will be collected during the study. Peripheral blood samples will be obtained for the assessment of immunological parameters, including cellular and cytokine profiles, and for PBMC collection. The observations will aim to describe immunological changes over the course of treatment and their association with patients’ clinical and treatment-related characteristics. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 20/02/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Female |
| Target sample size at registration | 70 |
| Total final enrolment | 99 |
| Key inclusion criteria | 1. Age ≥18 years 2. Female patients with breast cancer eligible for preoperative chemotherapy 3. Written informed consent |
| Key exclusion criteria | 1. Patients not eligible for preoperative chemotherapy 2. Inability to provide written informed consent |
| Date of first enrolment | 11/07/2019 |
| Date of final enrolment | 02/03/2023 |
Locations
Countries of recruitment
- Italy
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 Milano | 25/12/2021 | 21/05/2026 | No | Yes |
| Participant information sheet | in Italian version 1.0 Cuneo |
05/06/2020 | 21/05/2026 | No | Yes |
| Protocol file | version 1 | 05/06/2020 | 20/05/2026 | No | No |
| Protocol file | version 2 | 15/09/2021 | 20/05/2026 | No | No |
Additional files
- 49566 Protocol v1 (Italian) 05June2020.pdf
- Protocol file
- 49566 Protocol v2 (Italian) 15Sept2021.pdf
- Protocol file
- 49566 PIS Informativa e Modulo CI_NEORUNNER_Cuneo.pdf
- in Italian
- 49566 PIS Informativa e Modulo CI_NEORUNNER_Milano.pdf
- Participant information sheet
Editorial Notes
20/05/2026: Trial's existence confirmed by Azienda Ospedaliera S. Croce e Carle di Cuneo.
