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Physical Exercise During Preoperative Chemotherapy for Breast Cancer

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-11-09

    Primary completion: 2025-12-01

    Study completion finish: 2027-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05184582

    Intervention or treatment

    BEHAVIORAL: Physical training

    Conditions

    • Breast Cancer

    Find a site

    Closest Location:

    Cabrini Health

    Research sites nearby

    Select from list below to view details:

    • Cabrini Health

      Melbourne, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    NO_INTERVENTION: Standard
    • Routine information on the benefit of physical activity
    Not specified
    EXPERIMENTAL: Intervention
    • High-intensity interval and strength training during neoadjuvant chemotherapy
    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).

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Pathological complete responseAbsence of residual invasive tumor in breast and axilla at surgery5-6 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Global health-related quality of lifeassessed by the EORTC QLQ-C30 questionnairebaseline, after 1 and 2 years
    Breast cancer-related quality of lifeassessed by the EORTC QLQ-B23 questionnairebaseline, after 1 and 2 years
    Self-reported physical activityModified Godin Leisure Time Physical activity questionnairebaseline, pre-surgery, 1- and 2-year follow-up
    Chemotherapy completion rateproportion of participants receiving the planned number of treatments1 year
    Cumulative chemotherapy dosagetotal dose of NACT received to account for potential dose reduction1 year
    Objective cognitive dysfunctiononline neuropsychological test (Amsterdam Cognition Scan)baseline and 1 year
    Sick leavePatient-reported absence from workpre-surgery and at 1- and 2-year follow-up
    Device-measured physical activity levelFit-bit trackerbaseline and 5-6months (pre surgery)
    Muscle strengthhypothetical 1-RM maximal leg muscle strength testbaseline and 5-6 months
    Handgrip strengthhandgrip strength testbaseline and 5-6 months
    Cardiorespiratory fitnessÅstrand submaximal cycle testbaseline and 5-6 months (pre-surgery)
    Radiological tumour responseRECIST5-6 months
    Residual Cancer Burden (RCB)Degree of tumor response to NACT5-6 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Physical Exercise During Preoperative Chemotherapy for Breast Cancer

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