NCT05957068

Breast Cancer Exercise Intervention Study

Breast Cancer Exercise Intervention Study (BREXINT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,156 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Early-stage Breast Cancer
• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
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.
BEHAVIORAL	Control	Usual care group.

Timeline

• Start date: 2023-07-01
• Primary completion: 2028-05-31
• Completion: 2033-05-31
• First posted: 2023-07-24
• Last updated: 2025-09-05

Locations

3 sites across 1 country: Singapore