At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Physical training (behavioural)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Physical training — behavioural: Participants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Karolinska Institutet, is looking at physical exercise during chemotherapy given before surgery for breast cancer. Chemotherapy given before an operation is called neoadjuvant chemotherapy (NACT).
Who can take part
- Adults aged 18 or over
- People with primary invasive breast cancer at certain stages (cT1-T3 cN0-2)
- Full tumour biology results available before starting chemotherapy
- Able to give consent by mouth and in writing
Who may not be able to
- People who are pregnant or breast-feeding
- Cancer in both breasts that is invasive
- Health conditions affecting muscles, joints, nerves, breathing, metabolism or the heart that could make the exercise unsafe
- Already doing 150 minutes or more of moderate to high intensity aerobic exercise each week, plus 2 sessions a week of moderate intensity resistance exercise
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 712
- Started
- 2022-11-09
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • NA - 712 participants
- • Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with breast cancer
Where?
- • Edinburgh - Edinburgh Napier University
- • London - Royal Marsden
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The Neo-ACT assesses the primary endpoint pathological complete response (pCR) and the secondary endpoints Residual Cancer Burden (RCB), objective tumour response (RECIST), all-cause, breast cancer-specific, and recurrence-free survival at 2, 5 and 10 years, health-related quality of life assessed by the EORTC QLQ-C30 and BR23 questionnaires, self-reported physical activity (Modified Godin Leisure Time Physical activity questionnaire), toxicity-related outcomes (chemotherapy completion rates, number of unplanned hospital admissions during NACT, objective cognitive dysfunction (Amsterdam Cognition Scan), cardiac toxicity and sick leave), device-measured physical activity level (Fitbit activity tracker), muscle strength (handgrip strength test and hypothetical 1-RM maximal leg muscle strength tests), and cardiorespiratory fitness (Ekblom-Bak submaximal cycle test). 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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Pregnancy or breast-feeding
- ✗Bilateral invasive breast cancer
- ✗The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent...
- ✗Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions...
See the full criteria
Where Is This Study? (2 UK sites)
Edinburgh Napier University
Edinburgh, United Kingdom
Royal Marsden
London, United Kingdom
How to Get in Touch
Jana de Boniface
Sponsor contactCONTACT
Cecilia Haddad Ringborg
Sponsor contactCONTACT