Physical Exercise During Preoperative Chemotherapy for Breast Cancer
NCT ID: NCT05184582
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
712 participants
INTERVENTIONAL
2022-11-09
2028-06-30
Brief Summary
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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.
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Detailed Description
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Participants randomized to the exercise group will complete 120 min exercise sessions per week from initiation of NACT to surgery (approx. five months):
* Progressive home exercise program by an individualised mobile phone application, supported by local physiotherapists
* Initial exercise intensity individually tailored to each patient's fitness at baseline and rate of perceived exertion during the program and adapted if required
* Sessions will begin with a 3-minute moderate intensity (12-13 on Borg's Rate of Perceived Exertion (RPE) scale) warm-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard
Routine information on the benefit of physical activity
No interventions assigned to this group
Intervention
High-intensity interval and strength training during neoadjuvant chemotherapy
Physical training
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).
Interventions
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Physical training
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).
Eligibility Criteria
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Inclusion Criteria
* Full tumour biology available before initiation of NACT
* Oral and written consent
* Age ≥ 18 years
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Jana de Boniface
Ass. Prof, PI
Principal Investigators
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Jana de Boniface
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Cabrini Health
Melbourne, , Australia
Helsinki University Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skaraborgs sjukhus
Lidköping, , Sweden
Capio St Görans Hospital
Stockholm, , Sweden
Southern General Hospital
Stockholm, , Sweden
Sundsvall Hospital
Sundsvall, , Sweden
Umeå University Hospital
Umeå, , Sweden
Västmanlands Hospital
Västerås, , Sweden
Edinburgh Napier University
Edinburgh, Scotland, United Kingdom
Royal Marsden
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Eva Zopf
Role: primary
Peeter Karihtala
Role: primary
Eeva Juhanoja
Role: primary
Per Nyman
Role: primary
Jana de Boniface
Role: primary
Sara Margolin
Role: primary
Anna-Karin Wennstig
Role: primary
Hanna Röjlar
Role: primary
Yvette Andersson
Role: primary
Frankie Brown
Role: primary
Marios Tasoulis
Role: primary
References
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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.
Other Identifiers
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Neo-ACT
Identifier Type: -
Identifier Source: org_study_id
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