Physical Exercise During Preoperative Chemotherapy for Breast Cancer

NCT05184582 | Recruiting DMC

• 1 other identifier: Neo-ACT
• Study Type: interventional
• Target: 712
• Locations: 4 countries
• Sites: 13

Brief Summary

Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes. The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses. 712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Absence of residual invasive tumor in breast and axilla at surgery

  5-6 months

Secondary Outcomes (13)

• Global health-related quality of life

  baseline, after 1 and 2 years

• Breast cancer-related quality of life

  baseline, after 1 and 2 years

• Self-reported physical activity

  baseline, pre-surgery, 1- and 2-year follow-up

• Chemotherapy completion rate

  1 year

• Cumulative chemotherapy dosage

  1 year

Study Arms (2)

Standard

NO INTERVENTION

Routine information on the benefit of physical activity

Intervention

EXPERIMENTAL

High-intensity interval and strength training during neoadjuvant chemotherapy

Behavioral: Physical training

Interventions

Physical training BEHAVIORAL

Participants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months).

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary invasive breast cancer cT1-T3 cN0-2
• Full tumour biology available before initiation of NACT
• Oral and written consent
• Age ≥ 18 years

You may not qualify if:

• Pregnancy or breast-feeding
• Bilateral invasive breast cancer
• The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
• Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (13)

Cabrini Health

Melbourne, Australia

NOT YET RECRUITING

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skaraborgs sjukhus

Lidköping, Sweden

RECRUITING

Capio St Görans Hospital

Stockholm, Sweden

RECRUITING

Southern General Hospital

Stockholm, Sweden

RECRUITING

Sundsvall Hospital

Sundsvall, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Västmanlands Hospital

Västerås, Sweden

RECRUITING

Edinburgh Napier University

Edinburgh, Scotland, United Kingdom

NOT YET RECRUITING

Royal Marsden

London, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• de Boniface J, Altena R, Haddad Ringborg C, Bolam KA, Wengstrom Y. Physical exercise during neoadjuvant chemotherapy for breast cancer as a mean to increase pathological complete response rates: Trial protocol of the randomized Neo-ACT trial. PLoS One. 2022 Oct 13;17(10):e0274804. doi: 10.1371/journal.pone.0274804. eCollection 2022.

  PMID: 36227931 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jana de Boniface

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana de Boniface

CONTACT

+46702472305; jana.de-boniface@ki.se

Cecilia Haddad Ringborg

CONTACT

cecilia.haddad.ringborg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof, PI

Model Details: Randomization to supervised high-intensity interval training during neoadjuvant chemotherapy or usual information about physical activity.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 11, 2022
• Study Start: November 9, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study protocol, SAP and ICF available on trial homepage presently. Open access. CSR and analytic code available on request, see above.

Locations

GB (2); AU (1); FI (2); SE (8)