Breast Cancer Exercise Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-99
SponsorNational Cancer Centre, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Programme
BehavioralAerobic 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
BehavioralUsual care group.
Treatment groups
2,156 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease-Free Survival (DFS)
From the date of randomization to when an event, i.e. relapse, has occurred.
Time frame
Up to 5 years.Secondary outcomes
1
Overall Survival (OS)
From the date of randomization to when an event, i.e. death, has occurred.
Time frame
Up to 5 years.Other outcomes
1
Body fat/muscle ratio.
Body fat mass (in grams) divided by body muscle mass (in grams).
Time frame
Week 0, Week 8, Week 16 and Week 24.2
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.
Time frame
Week 8, Week 16 and Week 24.3
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.
Time frame
Week 8, Week 16 and Week 24.4
Changes in oxygen pulse (VO2/HR) during CPET.
Changes in oxygen pulse (VO2/HR) during CPET, at 8, 16, and 24 weeks from baseline.
Time frame
Week 8, Week 16 and Week 24.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Centre, Singapore
Lead sponsor
Singapore Cancer Society
Collaborator
Genome Institute of Singapore
Collaborator
National University of Singapore
Collaborator
Singapore General Hospital
Collaborator
Source ClinicalTrials.gov