Breast Cancer Exercise Intervention Study
BREXINT
1 other identifier
interventional
2,156
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2033
September 5, 2025
September 1, 2025
4.9 years
June 13, 2023
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival (DFS)
From the date of randomization to when an event, i.e. relapse, has occurred.
Up to 5 years.
Secondary Outcomes (1)
Overall Survival (OS)
Up to 5 years.
Other Outcomes (9)
Body fat/muscle ratio.
Week 0, Week 8, Week 16 and Week 24.
Changes in absolute and relative VO2.
Week 8, Week 16 and Week 24.
Changes in heart rate at rest and during CPET.
Week 8, Week 16 and Week 24.
- +6 more other outcomes
Study Arms (2)
Exercise
EXPERIMENTALThe exercise intervention group will undergo an aerobic exercise and strength training programme, comprising 3 sessions per week, spanning 24 weeks (total: 3x24=72 sessions).
Control
EXPERIMENTALThe usual care group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
- Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Centre, Singaporelead
- Singapore Cancer Societycollaborator
- Genome Institute of Singaporecollaborator
- National University of Singaporecollaborator
- Singapore General Hospitalcollaborator
Study Sites (3)
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 168583, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Elaine LIM, MD, PhD
National Cancer Centre, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
July 24, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2033
Last Updated
September 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Once data is available, only de-identified IPD will be shared to collaborators.