RecruitingNot ApplicableNCT05184582

Physical Exercise During Preoperative Chemotherapy for Breast Cancer

Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial


Sponsor

Karolinska Institutet

Enrollment

712 participants

Start Date

Nov 9, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

  • 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

Exclusion Criteria4

  • 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

Interventions

BEHAVIORALPhysical 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).


Locations(13)

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

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NCT05184582


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