Clinical trial · Interventional
Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer
Neo-train: Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer - a Randomized Controlled Trial
NCT04623554CI-TRIAL-00102262Neo-trainactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention arm
- description
- Prehabilitation program
- interventionNames
- Behavioral: Prehabilitation program
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Usual care
Primary outcomes (1)
- measure
- Tumour size
- timeFrame
- 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.
- description
- Change in the maximum diameter of the tumour visualized by magnetic resonance imaging (MRI).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDKjeldsted 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
- RESULTKjeldsted 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