Breast Cancer Exercise Intervention Study (BREXINT)

National Cancer Centre, Singapore

Status: Enrolling

Conditions: Locally Advanced Breast Cancer; Early-stage Breast Cancer

Treatments: Behavioral: Control; Behavioral: Exercise Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT05957068

BREXINT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,156 estimated patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,156 participants in 2 patient groups

Exercise

Experimental group

Description:

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).

Treatment:

Behavioral: Exercise Programme

Control

Experimental group

Description:

The usual care group.

Treatment:

Behavioral: Control