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

Plain Language Summary

Simplified for easier understanding

This study is examining whether a structured exercise program during preoperative chemotherapy (given before surgery to shrink the tumor) improves physical fitness and treatment outcomes in women with early-stage invasive breast cancer. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with invasive breast cancer (stage T1–T3, N0–N2) and are about to begin neoadjuvant chemotherapy (chemo before surgery) - Full tumor biology (hormone receptor status, HER2, etc.) is available before starting chemotherapy - You have given written and verbal consent **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have cancer in both breasts - You have a musculoskeletal, neurological, respiratory, metabolic, or heart condition that makes exercise unsafe - You are already exercising at a high level (150+ minutes per week of moderate-to-vigorous aerobic exercise and 2 or more resistance sessions per week) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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