Effect of moderate physical exercise on the immune system in patients with breast cancer receiving preoperative chemotherapy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10851800

Enrollment

Registered

2026-06-17

Start date

2019-07-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer

Interventions

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 physic

Eligibility

Sex/Gender

Female

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Female patients with breast cancer eligible for preoperative chemotherapy 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients not eligible for preoperative chemotherapy 2. Inability to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Cellular and cytokine immune profile measured using Flow cytometry for circulating immune cell populations; commercially available ELISA/cytokine assay kits for cytokines and interleukins; complete blood count and LDH according to local laboratory procedures at T0: before the start of chemotherapy; T1: before the start of exercise training; T2: the day before surgery; T3: 48–72 hours after surgery; T4: approximately 6 months after completion of chemotherapy	—

Measure

Time frame

Cellular and cytokine immune profile measured using Flow cytometry for circulating immune cell populations; commercially available ELISA/cytokine assay kits for cytokines and interleukins; complete blood count and LDH according to local laboratory procedures at T0: before the start of chemotherapy; T1: before the start of exercise training; T2: the day before surgery; T3: 48–72 hours after surgery; T4: approximately 6 months after completion of chemotherapy

—

Secondary

Measure	Time frame
Association between immune profile changes and clinical outcomes measured using Correlation between changes in cellular and cytokine immune parameters and disease-free survival and overall survival, using clinical data extracted from medical records and hospital databases at During follow-up, up to 12 months after completion of patient enrolment and according to available clinical follow-up data	—

Countries

Italy

Contacts

Public ContactOrnella Garrone

ornella.garrone@gmail.com0255032660

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026