Breast Cancer Exercise Intervention Study

Not Applicable

Recruiting

• Conditions: Early-stage Breast Cancer; Locally Advanced Breast Cancer
• Interventions: Behavioral: Exercise Programme; Behavioral: Control

• Registration Number: NCT05957068
• Lead Sponsor: National Cancer Centre, Singapore

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.

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 Timeline

• Study First Submitted: 2023-06-13
• Study Start: 2023-07-01
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2028-05-31
• Study Completion: 2033-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise Programme	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).
Control	Control	The usual care group.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall Survival (OS)	Up to 5 years.	From the date of randomization to when an event, i.e. death, has occurred.

Trial Locations

Locations (3)

National University Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore

National Cancer Centre; 🇸🇬 Singapore, Singapore