Study Protocol Neo-ACT

The Neo-ACT trial includes patients according to the following inclusion and exclusion criteria:

Inclusion criteria

  • Patients with primary invasive breast cancer (cT1-T3 cNO-2)
  • Full tumour biology available before initiation of NACT (ER, PR, HER2, tumour grade, and Ki67)
  • Signed informed consent
  • Age above 18 years old

Exclusion criteria

  • Pregnancy and breast-feeding
  • Inability to absorb or understand the meaning of the study
  • The presence od 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 minutes of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise (WHO criteria) 
  • Participation in other neoadjuvant intervention trial with conflicting endpoint

After signing the informed consent form, patient will be randomised to one of two groups:

Standard care group: Usual care

Intervention group: Physical exercise intervention

Stratification at the moment of computerized randomization will be done based on site of treatment (hospital) and biological tumour subtype (ER+HER2-, ER+HER2+, ER-HER2+, ER-HER2-).

For further details on treatment, follow-up and registration please refer to Study Protocol.

In order to access patient information, please refer to tab “PATIENT INFORMATION”.

Intervention

Participants randomised to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months) via a mobile application.

Participants will receive instructions by an exercise physiologist or physiotherapist and perform training via the individualised training mobile application Vitala, supported by contact with a local physiotherapist/physiologist and remotely via phone. The Vitala mobile phone application provides exercise instructions and support and measures program adherence and symptom reporting. Videos of variations of the resistance training and high-intensity interval training (HIIT) exercises are included in the app and are individually adapted to each participant. Initial exercise intensity will be individually tailored to each patient’s fitness at baseline and rate of perceived exertion during the program and adapted if required.

Aerobic exercise component

The first two weeks will include continuous moderate intensity aerobic exercise (15 mins) to familiarise the patients with the exercise program before starting the interval training. From week 3 onwards, the patients will progress to high-intensity interval training which will be 3 x 3-minute intervals completed on high-intensity Tabata type activities with 2 minutes of passive or active recovery in between bouts.

Resistance exercise component

Moderate intensity progressive resistance exercises will include ~7 exercises e.g. chest and leg press, seated row, bicep curl, triceps press, leg curl, and abdominal exercises performed as home-based exercises. In addition, patients will be encouraged to accumulate 150 minutes of physical activity each week (for example walking or bicycling).

Tests

  • Device-measured physical activity level and resting heart rate assessed through the Fitbit activity tracker (baseline to pre-surgery).
  • Muscle strength assessed through the handgrip strength test and hypothetical 1RM maximal leg muscle strength tests (baseline and pre-surgery).
  • Cardiorespiratory fitness assessed by the Ekblom-Bak submaximal cycle test (baseline and pre-surgery).