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NCT Number: NCT05957068

Breast Cancer Exercise Intervention Study

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.

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Programme

Behavioral

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.

Control

Behavioral

Usual care group.

Primary outcomes

  1. Disease-Free Survival (DFS)

    Time frame: Up to 5 years.

    From the date of randomization to when an event, i.e. relapse, has occurred.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 years.

    From the date of randomization to when an event, i.e. death, has occurred.

Other outcomes

  1. Body fat/muscle ratio.

    Time frame: Week 0, Week 8, Week 16 and Week 24.

    Body fat mass (in grams) divided by body muscle mass (in grams).

  2. Changes in absolute and relative VO2.

    Time frame: 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.

  3. Changes in heart rate at rest and during CPET.

    Time frame: 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.

  4. Changes in oxygen pulse (VO2/HR) during CPET.

    Time frame: Week 8, Week 16 and Week 24.

    Changes in oxygen pulse (VO2/HR) during CPET, at 8, 16, and 24 weeks from baseline.

  5. Changes in respiratory exchange ratio (RER) during CPET.

    Time frame: Week 8, Week 16 and Week 24.

    Changes in respiratory exchange ratio (RER, unitless) during CPET, at 8, 16, and 24 weeks from baseline

  6. Changes in weight lifted 10 repetition maximum.

    Time frame: 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.

  7. Changes in absolute fat mass and relative fat mass from baseline.

    Time frame: 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.

  8. Changes in absolute lean mass and relative lean mass from baseline.

    Time frame: 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.

  9. Changes in absolute and relative bone mineral density (BMD) at 8, 16, and 24 weeks from baseline.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine CELES

CONTACT

[email protected]

Dr Elaine LIM, MD, PhD

CONTACT

[email protected]

+65 64368000

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • Genome Institute of Singapore
  • National University of Singapore
  • Singapore Cancer Society
  • Singapore General Hospital

Registry information

Official study title

Breast Cancer Exercise Intervention Study (BREXINT)

Acronym: BREXINT

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Jul 24, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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