Breast Cancer Exercise Intervention Study

Early-stage Breast Cancer Clinical Trial

— BREXINT  

Official title:

Breast Cancer Exercise Intervention Study (BREXINT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957068
• Other study ID #: BREXINT
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: May 31, 2033

Study information

• Verified date: July 2023
• Source: National Cancer Centre, Singapore
• Contact: Dr Elaine LIM, MD, PhD
• Phone: +65 64368000
• Email: elaine.lim.hsuen[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2156
• Est. completion date: May 31, 2033
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer
• Locally Advanced Breast Cancer

Intervention

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.
• Control
Usual care group.

Locations

Country	Name	City	State
Singapore	National Cancer Centre	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Genome Institute of Singapore, National University of Singapore, Singapore Cancer Society, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body fat/muscle ratio.	Body fat mass (in grams) divided by body muscle mass (in grams).	Week 0, Week 8, Week 16 and Week 24.
Other	Changes in absolute and relative VO2.	Changes in absolute (L/min) and relative VO2 (mL/kg/min) at 8, 16 and 24 weeks from baseline.	Week 8, Week 16 and Week 24.
Other	Changes in heart rate at rest and during CPET.	Changes in heart rate (HR, beats/min) at rest and during CPET, at 8, 16 and 24 weeks from baseline.	Week 8, Week 16 and Week 24.
Other	Changes in oxygen pulse (VO2/HR) during CPET.	Changes in oxygen pulse (VO2/HR) during CPET, at 8, 16, and 24 weeks from baseline.	Week 8, Week 16 and Week 24.
Other	Changes in respiratory exchange ratio (RER) during CPET.	Changes in respiratory exchange ratio (RER, unitless) during CPET, at 8, 16, and 24 weeks from baseline	Week 8, Week 16 and Week 24.
Other	Changes in weight lifted 10 repetition maximum.	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.	Week 0, Week 8, Week 16 and Week 24.
Other	Changes in absolute fat mass and relative fat mass from baseline.	Changes in absolute fat mass (kg) and relative fat mass (%) at 8, 16, and 24 weeks from baseline.	Week 8, Week 16 and Week 24.
Other	Changes in absolute lean mass and relative lean mass from baseline.	Changes in absolute lean mass (kg) and relative lean mass (%) at 8, 16, and 24 weeks from baseline.	Week 8, Week 16 and Week 24.
Other	Changes in absolute and relative bone mineral density (BMD) at 8, 16, and 24 weeks from baseline.	Changes in absolute and relative bone mineral density (BMD, in g/cm^2) at 8, 16, and 24 weeks from baseline.	Week 8, Week 16 and Week 24.
Primary	Disease-Free Survival (DFS)	From the date of randomization to when an event, i.e. relapse, has occurred.	Up to 5 years.
Secondary	Overall Survival (OS)	From the date of randomization to when an event, i.e. death, has occurred.	Up to 5 years.