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

NCT04623554 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Region Zealand

    collaborator OTHER

  • Naestved, Slagelse and Ringsted Hospitals

    collaborator UNKNOWN

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Susanne Dalton, Prof. · Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2024-02-15
Completion
2034-02-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623554 on ClinicalTrials.gov