Physical Exercise During Preoperative Chemotherapy for Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Physical training
- Registration Number
- NCT05184582
- Lead Sponsor
- Karolinska Institutet
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 712
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Physical training High-intensity interval and strength training during neoadjuvant chemotherapy
- Primary Outcome Measures
Name Time Method Pathological complete response 5-6 months Absence of residual invasive tumor in breast and axilla at surgery
- Secondary Outcome Measures
Name Time Method Global health-related quality of life baseline, after 1 and 2 years assessed by the EORTC QLQ-C30 questionnaire
Sick leave pre-surgery and at 1- and 2-year follow-up Patient-reported absence from work
Chemotherapy completion rate 1 year proportion of participants receiving the planned number of treatments
Cumulative chemotherapy dosage 1 year total dose of NACT received to account for potential dose reduction
Device-measured physical activity level baseline and 5-6months (pre surgery) Fit-bit tracker
Handgrip strength baseline and 5-6 months handgrip strength test
Breast cancer-related quality of life baseline, after 1 and 2 years assessed by the EORTC QLQ-B23 questionnaire
Self-reported physical activity baseline, pre-surgery, 1- and 2-year follow-up Modified Godin Leisure Time Physical activity questionnaire
Muscle strength baseline and 5-6 months hypothetical 1-RM maximal leg muscle strength test
Radiological tumour response 5-6 months RECIST
Objective cognitive dysfunction baseline and 1 year online neuropsychological test (Amsterdam Cognition Scan)
Cardiorespiratory fitness baseline and 5-6 months (pre-surgery) Åstrand submaximal cycle test
Residual Cancer Burden (RCB) 5-6 months Degree of tumor response to NACT
Trial Locations
- Locations (13)
Cabrini Health
🇦🇺Melbourne, Australia
Turku University Hospital
🇫🇮Turku, Finland
Helsinki University Hospital
🇫🇮Helsinki, Finland
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Skaraborgs sjukhus
🇸🇪Lidköping, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Southern General Hospital
🇸🇪Stockholm, Sweden
Capio St Görans Hospital
🇸🇪Stockholm, Sweden
Sundsvall Hospital
🇸🇪Sundsvall, Sweden
Umeå University Hospital
🇸🇪Umeå, Sweden
Edinburgh Napier University
🇬🇧Edinburgh, Scotland, United Kingdom
Västmanlands Hospital
🇸🇪Västerås, Sweden
Royal Marsden
🇬🇧London, United Kingdom