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NCT Number: NCT04623554

Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Oncology and Palliative Care, Zealand University Hospital

Næstved, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation program

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. Number of participants with neoadjuvant chemotherapy dose reductions

    Time frame: Baseline to time of breast surgery estimated up to 30 weeks

    Measured in percentage

  3. Number of participants with neoadjuvant chemotherapy dose delays

    Time frame: Baseline to time of breast surgery estimated up to 30 weeks

    Measured in percentage

  4. 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

  5. Number of hospital admissions during neoadjuvant chemotherapy

    Time frame: Baseline to time of breast surgery estimated up to 30 weeks

    Measured in percentage

  6. Total length of hospital admissions during neoadjuvant chemotherapy

    Time frame: Baseline to time of breast surgery estimated up to 30 weeks

    Measured in days

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. Recurrence

    Time frame: Breast surgery to up to 10 years follow-up after breast surgery

    Incidence of breast cancer recurrence in percent

  29. Survival

    Time frame: Breast surgery to up to 10 years follow-up after breast surgery

    Risk of mortality

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Neo-train

Important dates

Study start
2021
Primary completion
2024
Study completion
2034
First posted
Nov 10, 2020
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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