BREXINT: Breast Cancer Exercise Intervention Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise 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
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.
|
| Experimental: Control The usual care group. |
Behavioral: Control
Usual care group.
|
Outcome Measures
Primary Outcome Measures
- Disease-Free Survival (DFS) [Up to 5 years.]
From the date of randomization to when an event, i.e. relapse, has occurred.
Secondary Outcome Measures
- Overall Survival (OS) [Up to 5 years.]
From the date of randomization to when an event, i.e. death, has occurred.
Other Outcome Measures
- Body fat/muscle ratio. [Week 0, Week 8, Week 16 and Week 24.]
Body fat mass (in grams) divided by body muscle mass (in grams).
- Changes in absolute and relative VO2. [Week 8, Week 16 and Week 24.]
Changes in absolute (L/min) and relative VO2 (mL/kg/min) at 8, 16 and 24 weeks from baseline.
- Changes in heart rate at rest and during CPET. [Week 8, Week 16 and Week 24.]
Changes in heart rate (HR, beats/min) at rest and during CPET, at 8, 16 and 24 weeks from baseline.
- Changes in oxygen pulse (VO2/HR) during CPET. [Week 8, Week 16 and Week 24.]
Changes in oxygen pulse (VO2/HR) during CPET, at 8, 16, and 24 weeks from baseline.
- Changes in respiratory exchange ratio (RER) during CPET. [Week 8, Week 16 and Week 24.]
Changes in respiratory exchange ratio (RER, unitless) during CPET, at 8, 16, and 24 weeks from baseline
- Changes in weight lifted 10 repetition maximum. [Week 0, Week 8, Week 16 and Week 24.]
Changes in weight lifted 10 repetition maximum (10-RM, Kg) for: a. Chest press; b. Latissimus pull-down; c. 2-arm curl; and d. Leg press.
- Changes in absolute fat mass and relative fat mass from baseline. [Week 8, Week 16 and Week 24.]
Changes in absolute fat mass (kg) and relative fat mass (%) at 8, 16, and 24 weeks from baseline.
- Changes in absolute lean mass and relative lean mass from baseline. [Week 8, Week 16 and Week 24.]
Changes in absolute lean mass (kg) and relative lean mass (%) at 8, 16, and 24 weeks from baseline.
- Changes in absolute and relative bone mineral density (BMD) at 8, 16, and 24 weeks from baseline. [Week 8, Week 16 and Week 24.]
Changes in absolute and relative bone mineral density (BMD, in g/cm^2) at 8, 16, and 24 weeks from baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer
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Patients who have undergone curative breast surgery
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Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given)
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Females aged 21 years and older
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≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.
Exclusion Criteria:
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Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
-
Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National University Hospital | Singapore | Singapore | 119074 | |
| 2 | National Cancer Centre | Singapore | Singapore | 168583 | |
| 3 | Singapore General Hospital | Singapore | Singapore | 169608 |
Sponsors and Collaborators
- National Cancer Centre, Singapore
- Singapore Cancer Society
- Genome Institute of Singapore
- National University of Singapore
- Singapore General Hospital
Investigators
- Principal Investigator: Dr Elaine LIM, MD, PhD, National Cancer Centre, Singapore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BREXINT