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Trial Title:
Breast Cancer Exercise Intervention Study
NCT ID:
NCT05957068
Condition:
Early-stage Breast Cancer
Locally Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
BREXINT
Muscular Strength
Cardiorespiratory Fitness
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Programme
Description:
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.
Arm group label:
Exercise
Intervention type:
Behavioral
Intervention name:
Control
Description:
Usual care group.
Arm group label:
Control
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.
Criteria for 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.
Gender:
Female
Minimum age:
21 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Professor Soo Chin LEE, MD
Phone:
+65 67737888
Email:
ncis@nuhs.edu.sg
Facility:
Name:
National Cancer Centre
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Singapore General Hospital
Address:
City:
Singapore
Zip:
169608
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Dr Veronique TAN, MD
Phone:
+65 62223322
Email:
veronique.tan.k.m@singhealth.com.sg
Start date:
July 1, 2023
Completion date:
May 31, 2033
Lead sponsor:
Agency:
National Cancer Centre, Singapore
Agency class:
Other
Collaborator:
Agency:
Singapore Cancer Society
Agency class:
Other
Collaborator:
Agency:
Genome Institute of Singapore
Agency class:
Other
Collaborator:
Agency:
National University of Singapore
Agency class:
Other
Collaborator:
Agency:
Singapore General Hospital
Agency class:
Other
Source:
National Cancer Centre, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957068
