Breast Cancer Exercise Intervention Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Programme, Control.
- Who it may be relevant to
- Registry conditions: Early-stage Breast Cancer, Locally Advanced Breast Cancer. Basic parameters: 21 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Cancer Exercise Intervention Study (BREXINT)
Overview
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
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.
Interventions
- Behavioral Exercise Programme
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 - Behavioral Control
Usual care group.
Primary outcome measures
- Disease-Free Survival (DFS) [Time frame: Up to 5 years.]
Secondary outcome measures (1)
- Overall Survival (OS) [Time frame: Up to 5 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Singapore · 3 centers
- National University Hospital — Singapore
- National Cancer Centre — Singapore
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT05957068 · BREXINT