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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05184582
Other study ID # Neo-ACT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date December 2027

Study information

Verified date March 2024
Source Karolinska Institutet
Contact Jana de Boniface
Phone +46702472305
Email jana.de-boniface@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 712
Est. completion date December 2027
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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).

Locations

Country Name City State
Australia Cabrini Health Melbourne
Finland Helsinki University Hospital Helsinki
Finland Turku University Hospital Turku
Sweden Sahlgrenska University Hospital Gothenburg
Sweden Skaraborgs sjukhus Lidköping
Sweden Capio St Görans Hospital Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden Southern General Hospital Stockholm
Sweden Sundsvall Hospital Sundsvall
Sweden Umeå University Hospital Umeå
Sweden Västmanlands Hospital Västerås
United Kingdom Edinburgh Napier University Edinburgh Scotland
United Kingdom Royal Marsden London

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Countries where clinical trial is conducted

Australia,  Finland,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathological complete response Absence of residual invasive tumor in breast and axilla at surgery 5-6 months
Secondary Global health-related quality of life assessed by the EORTC QLQ-C30 questionnaire baseline, after 1 and 2 years
Secondary Breast cancer-related quality of life assessed by the EORTC QLQ-B23 questionnaire baseline, after 1 and 2 years
Secondary Self-reported physical activity Modified Godin Leisure Time Physical activity questionnaire baseline, pre-surgery, 1- and 2-year follow-up
Secondary Chemotherapy completion rate proportion of participants receiving the planned number of treatments 1 year
Secondary Cumulative chemotherapy dosage total dose of NACT received to account for potential dose reduction 1 year
Secondary Objective cognitive dysfunction online neuropsychological test (Amsterdam Cognition Scan) baseline and 1 year
Secondary Sick leave Patient-reported absence from work pre-surgery and at 1- and 2-year follow-up
Secondary Device-measured physical activity level Fit-bit tracker baseline and 5-6months (pre surgery)
Secondary Muscle strength hypothetical 1-RM maximal leg muscle strength test baseline and 5-6 months
Secondary Handgrip strength handgrip strength test baseline and 5-6 months
Secondary Cardiorespiratory fitness Åstrand submaximal cycle test baseline and 5-6 months (pre-surgery)
Secondary Radiological tumour response RECIST 5-6 months
Secondary Residual Cancer Burden (RCB) Degree of tumor response to NACT 5-6 months
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