Breast Cancer Exercise Intervention Study

NCT ID: NCT05957068

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2033-05-31

Brief Summary

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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

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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

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Early-stage Breast Cancer Locally Advanced Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients will be randomised into 2 groups: exercise (intervention group, N = 1078) and usual care (control group, N = 1078). The exercise intervention group will undergo an aerobic exercise and strength training programme.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise Programme

Intervention Type 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

The usual care group.

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Usual care group.

Interventions

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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.

Intervention Type BEHAVIORAL

Control

Usual care group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Singapore Cancer Society

OTHER

Sponsor Role collaborator

Genome Institute of Singapore

OTHER

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Elaine LIM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

National Cancer Centre

Singapore, , Singapore

Site Status RECRUITING

Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Dr Elaine LIM, MD, PhD

Role: CONTACT

+65 64368000

Catherine CELES

Role: CONTACT

Facility Contacts

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Professor Soo Chin LEE, MD

Role: primary

+65 67737888

Dr Veronique TAN, MD

Role: primary

+65 62223322

Other Identifiers

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BREXINT

Identifier Type: -

Identifier Source: org_study_id

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