Breast Cancer Exercise Intervention Study

Study Overview
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Brief Summary
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This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.

Detailed Description
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This is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). Patients are stratified by centre (NCC/SGH, NUH), menopausal status, ER/PR status, body fat/muscle ratio. Cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period. Blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times. Questionnaires are periodically conducted to assess quality of life (QoL). A food diary is kept.

Official Title
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Breast Cancer Exercise Intervention Study (BREXINT)

Conditions
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Early-stage Breast Cancer, Locally Advanced Breast Cancer

Intervention / Treatment
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* Behavioral: Exercise Programme
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer Patients who have undergone curative breast surgery Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given) Females aged 21 years and older ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest. Exclusion Criteria: Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity. Major medical problems that are deemed by the investigator to be unsuitable for enrollment.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomised into 2 groups: exercise (intervention group, N = 1078) and usual care (control group, N = 1078). The exercise intervention group will undergo an aerobic exercise and strength training programme.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>The exercise intervention group will undergo an aerobic exercise and strength training programme, comprising 3 sessions per week, spanning 24 weeks (total: 3x24=72 sessions). | Behavioral: Exercise Programme<br>* Aerobic exercise consists of 20-minute brisk walks or jogs (5-6 km/h) on the treadmill each session, reaching a heart rate corresponding to 50%-70% of the patient's VO2max (VO2max is determined before embarking on the exercise programme). Study participants are expected to aim for 50% VO2max at the start of the exercise programme, and gradually increasing to 70% VO2max in subsequent exercise sessions. Strength training comprises a series of circuit resistance exercises targeting the major muscle groups. Patients will perform 2-4 sets of these exercises each session, 8-10 repetitions per set. Both aerobic exercise and strength training are done in the same session. With warm-up and cool-down, each session is estimated to take up 1 hour.<br>|
| Experimental: Control<br>The usual care group. | Behavioral: Control<br>* Usual care group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free Survival (DFS) | From the date of randomization to when an event, i.e. relapse, has occurred. | Up to 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | From the date of randomization to when an event, i.e. death, has occurred. | Up to 5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BREXINT, Muscular Strength, Cardiorespiratory Fitness, Quality of Life