Clinical trial NCT05957068: Breast Cancer Exercise Intervention Study
Official title: Breast Cancer Exercise Intervention Study (BREXINT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early-stage Breast Cancer
Locally Advanced Breast Cancer
Keywords: BREXINT
Muscular Strength
Cardiorespiratory Fitness
Quality of Life
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore Cancer Society
name: Genome Institute of Singapore
name: National University of Singapore
name: Singapore General Hospital
First posted: 2023-07-24
Enrollment: 2156
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: Up to 5 years.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years.
Other outcomes:
measure: Body fat/muscle ratio.
timeFrame: Week 0, Week 8, Week 16 and Week 24.
measure: Changes in absolute and relative VO2.
timeFrame: Week 8, Week 16 and Week 24.
measure: Changes in heart rate at rest and during CPET.
timeFrame: Week 8, Week 16 and Week 24.
measure: Changes in oxygen pulse (VO2/HR) during CPET.
timeFrame: Week 8, Week 16 and Week 24.
measure: Changes in respiratory exchange ratio (RER) during CPET.
timeFrame: Week 8, Week 16 and Week 24.
measure: Changes in weight lifted 10 repetition maximum.
timeFrame: Week 0, Week 8, Week 16 and Week 24.
measure: Changes in absolute fat mass and relative fat mass from baseline.
timeFrame: Week 8, Week 16 and Week 24.
measure: Changes in absolute lean mass and relative lean mass from baseline.
timeFrame: Week 8, Week 16 and Week 24.
measure: Changes in absolute and relative bone mineral density (BMD) at 8, 16, and 24 weeks from baseline.
timeFrame: Week 8, Week 16 and Week 24.
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: National Cancer Centre, Singapore
name: Dr Elaine LIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: