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

NCT04623554 | Active Not Recruiting

• 1 other identifier: REG-074-2020
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Prehabilitation; Pre-operative exercise; Breast cancer; Tumour regression; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Tumour size

  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 Outcomes (29)

• Relative dose intensity of neoadjuvant chemotherapy

  Baseline to time of breast surgery estimated up to 30 weeks

• Number of participants with neoadjuvant chemotherapy dose reductions

  Baseline to time of breast surgery estimated up to 30 weeks

• Number of participants with neoadjuvant chemotherapy dose delays

  Baseline to time of breast surgery estimated up to 30 weeks

• Number of participants with early discontinuation of neoadjuvant chemotherapy

  Baseline to time of breast surgery estimated up to 30 weeks

• Number of hospital admissions during neoadjuvant chemotherapy

  Baseline to time of breast surgery estimated up to 30 weeks

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Prehabilitation program

Behavioral: Prehabilitation program

Control arm

NO INTERVENTION

Usual care

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Clinical Oncology and Palliative Care, Zealand University Hospital

Næstved, Denmark

Location

Related Publications (2)

• Kjeldsted E, Ammitzboll G, Jorgensen LB, Lodin A, Bojesen RD, Ceballos SG, Rosthoj S, Laenkholm AV, Skou ST, Jack S, Gehl J, Dalton SO. Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer. BMC Cancer. 2023 Aug 19;23(1):777. doi: 10.1186/s12885-023-11284-5.

  PMID: 37598196 BACKGROUND

• Kjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416.

  PMID: 40788186 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Susanne Dalton, Prof.

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to blind the participants, care providers or investigators. However, the outcome assessors of the primary endpoint (MRI assessment) will not be informed of the patients' allocation. Further, the statistician and data manager are blinded as the group allocation will be coded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial with an intervention arm and a control arm

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 10, 2020
• Study Start: June 23, 2021
• Primary Completion: February 15, 2024
• Study Completion (Estimated): February 15, 2034
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

DK (1)