Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer (Neo-train)

January 29, 2026 updated by: Susanne Dalton, Zealand University Hospital

Neo-train: Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer - a Randomized Controlled Trial

The Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. A possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated.

120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60).

Participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers.

Participants in the control arm will receive usual care.

Outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up.

The participants will receive the recommended neoadjuvant chemotherapy regimens in Denmark - currently up to 24 weeks. With expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. The treatment plans will be individually modified based on tumour response and expected side effects to treatment. A subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. In these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery.

The study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Næstved, Denmark
        • Department of Clinical Oncology and Palliative Care, Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients newly diagnosed with histologically verified breast cancer and scheduled for neoadjuvant chemotherapy
  • Female gender
  • Aged ≥ 18 years old
  • Signed informed consent

Exclusion Criteria:

  • Patients ineligible for or who have declined to receive neoadjuvant chemotherapy
  • Contraindications to magnetic resonance imaging (MRI)
  • Physical or cognitive disabilities preventing exercise or physical testing
  • Inability to read and understand Danish
  • Based on clinical judgement, the physician assesses that the patient is not suitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Usual care
Active Comparator: Intervention arm
Prehabilitation program
Behavioral: Prehabilitation program
The prehabilitation program includes combined high-intensity interval training on a cycle ergometer and machine-based resistance exercise of large muscle groups supervised by a physiotherapist. Exercise sessions will take place in physiotherapy departments at local hospitals or in municipality rehabilitation centres 3 times a week during the neoadjuvant chemotherapy period and ending in the week before breast surgery (maximum estimated 29 weeks depending on number of chemotherapy cycles, dose delays and time of breast surgery). Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers. Participation will be monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour size
Time Frame: Sequential MRI scans follow the individual treatment plan in a period of up to 30 weeks from baseline (diagnostic MRI before start of neoadjuvant chemotherapy) to MRI performed by the end of the course of neoadjuvant chemotherapy before breast surgery.
Change in the maximum diameter of the tumour visualized by magnetic resonance imaging (MRI).
Sequential MRI scans follow the individual treatment plan in a period of up to 30 weeks from baseline (diagnostic MRI before start of neoadjuvant chemotherapy) to MRI performed by the end of the course of neoadjuvant chemotherapy before breast surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative dose intensity of neoadjuvant chemotherapy
Time Frame: Baseline to time of breast surgery estimated up to 30 weeks
Relative dose intensity in percentage defined as the ratio of received mg/m2 per week compared to planned mg/m2 per week according to standard guidelines.
Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with neoadjuvant chemotherapy dose reductions
Time Frame: Baseline to time of breast surgery estimated up to 30 weeks
Measured in percentage
Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with neoadjuvant chemotherapy dose delays
Time Frame: Baseline to time of breast surgery estimated up to 30 weeks
Measured in percentage
Baseline to time of breast surgery estimated up to 30 weeks
Number of participants with early discontinuation of neoadjuvant chemotherapy
Time Frame: Baseline to time of breast surgery estimated up to 30 weeks
Measured in percentage
Baseline to time of breast surgery estimated up to 30 weeks
Number of hospital admissions during neoadjuvant chemotherapy
Time Frame: Baseline to time of breast surgery estimated up to 30 weeks
Measured in percentage
Baseline to time of breast surgery estimated up to 30 weeks
Total length of hospital admissions during neoadjuvant chemotherapy
Time Frame: Baseline to time of breast surgery estimated up to 30 weeks
Measured in days
Baseline to time of breast surgery estimated up to 30 weeks
Changes in total body mass
Time Frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes from baseline measured by bioelectrical impedance analysis.
Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in lean body mass
Time Frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes from baseline measured by bioelectrical impedance analysis.
Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in fat mass
Time Frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes from baseline measured by bioelectrical impedance analysis.
Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in physical fitness
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in VO2 max estimated from maximum power output from baseline measured by a progressive cycle ergometer test (watt max test).
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in muscle strength
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in 1 repetition maximum strength from baseline measured on leg press and pull down.
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in physical function
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in hand grip strength from baseline measured by hand-held dynamometer in kilograms. Maximum kilograms obtained of 3 measurements on each hand.
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in level of physical activity
Time Frame: Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in activity data measured by a wearable objective measurement device.
Baseline, during the week before breast surgery, 3 months after breast surgery
Changes in health-related quality of life
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in self-reported health-related quality of life from baseline assessed on the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B).
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in general anxiety
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in self-reported general anxiety from baseline assessed on the Generalised Anxiety Disorder 7-item (GAD-7).
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in depression
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in self-reported depression from baseline assessed on the Patient Health Questionnaire-9 (PHQ-9).
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in psychological distress
Time Frame: Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Changes in self-reported psychological distress from baseline assessed on the Distress Thermometer (DT).
Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery
Post-operative referral to and participation in municipal rehabilitation programs
Time Frame: Breast surgery to 3 months after breast surgery
Frequency of participants referred to municipal rehabilitation, participation and types of activities attended identified from a self-reported questionnaire.
Breast surgery to 3 months after breast surgery
Tumour size
Time Frame: Sequential clinical examinations of the breast following the individual treatment plan in a period of up to 30 weeks from baseline to time of breast surgery
Assessed by doctors' clinical examination of the breast.
Sequential clinical examinations of the breast following the individual treatment plan in a period of up to 30 weeks from baseline to time of breast surgery
Tumour size
Time Frame: At time of breast surgery estimated to take place within 30 weeks from baseline
Measured by a pathologist from the tumour surgical specimen at breast surgery.
At time of breast surgery estimated to take place within 30 weeks from baseline
Pathological response grade
Time Frame: At time of breast surgery estimated to take place within 30 weeks from baseline
Assessed by a pathologist from the tumour surgical specimen at breast surgery.
At time of breast surgery estimated to take place within 30 weeks from baseline
Liquid biopsies
Time Frame: Baseline, approximately week 7, 13 and 19, 3 months after breast surgery
Changes in cell free DNA from blood samples. Furthermore, circulating tumour DNA will be investigated if possible.
Baseline, approximately week 7, 13 and 19, 3 months after breast surgery
Metabolic and inflammatory markers
Time Frame: Baseline, approximately week 13 and 19, 3 months after breast surgery
Changes in glucose, hba1c, zinc, magnesium, phosphate and C reactive protein (CRP) levels from blood samples.
Baseline, approximately week 13 and 19, 3 months after breast surgery
Cytokines
Time Frame: Baseline, approximately week 13 and 19, 3 months after breast surgery
Changes in cytokines from blood samples before, during and after neoadjuvant chemotherapy.
Baseline, approximately week 13 and 19, 3 months after breast surgery
Cell proliferation
Time Frame: Approximately between week 1-4 during neoadjuvant chemotherapy and within 6 weeks before breast surgery
In vitro cell proliferation response with sera collected from blood samples before and after exercise.
Approximately between week 1-4 during neoadjuvant chemotherapy and within 6 weeks before breast surgery
Tumour infiltrating lymphocyte population
Time Frame: Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Description of tumour infiltrating lymphocyte population (percentage of cells) evaluated by a pathologist from the tumour biopsy specimen taken before chemotherapy and tumour surgical specimen at breast surgery.
Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Tumour vascularity
Time Frame: Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Description of tumour vascularity density and structure evaluated by a pathologist from the tumour biopsy specimen taken before chemotherapy and tumour surgical specimen at breast surgery.
Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks
Recurrence
Time Frame: Breast surgery to up to 10 years follow-up after breast surgery
Incidence of breast cancer recurrence in percent
Breast surgery to up to 10 years follow-up after breast surgery
Survival
Time Frame: Breast surgery to up to 10 years follow-up after breast surgery
Risk of mortality
Breast surgery to up to 10 years follow-up after breast surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Danish Cancer Society
University Hospital Southampton NHS Foundation Trust
Region Zealand
Naestved, Slagelse and Ringsted Hospitals

Investigators

  • Principal Investigator: Susanne Dalton, Prof., Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2021

Primary Completion (Actual)

February 15, 2024

Study Completion (Estimated)

February 15, 2034

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-074-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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