Breast Neoplasm, Physical Activity
Conditions
Brief summary
The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.
Detailed description
Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy
Interventions
BEHAVIORALExercise
All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity. The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
Sponsors
NRG Oncology
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Participants are randomized to the intervention or control arm.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
3.1 Inclusion Criteria * Women with a breast cancer diagnosis (Stage I-IIIC) * Sedentary (\< 75 min/wk of moderate intensity exercise over the past month) * No previous history of anthracycline based chemotherapy * Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease) * Absence of contraindications for neoadjuvant chemotherapy * Scheduled to receive neoadjuvant chemotherapy * Primary attending oncologist approval 3.2
Exclusion criteria
* Absolute contraindications for exercise stress testing * acute myocardial infarction (3-5 days) * unstable angina * uncontrolled arrhythmias causing symptoms or hemodynamic compromise * syncope * acute endocarditis * acute myocarditis or pericarditis * uncontrolled heart failure * acute pulmonary embolus or pulmonary infarction * thrombosis of lower extremities * suspected dissecting aneurysm * uncontrolled asthma * pulmonary edema * room air desaturation at rest ≤85% * respiratory failure * acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise * mental impairment leading to inability to cooperate * decisional impairment * Non-English speaking * Women only diagnosed with ductal carcinoma in situ * Women diagnosed with stage 4 metastatic breast cancer * Pregnant women * Men * Children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. | 4 weeks | Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study. |
| Participant Adherence to the Exercise Intervention | Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion) | Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor. |
| Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection | Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline) | Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control We ask that participants in the control arm do not start an exercise program. | 10 |
| Exercise Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max. | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Exercise | Total | Control |
|---|---|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 11.7 | 49.4 years STANDARD_DEVIATION 10.5 | 51.5 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 4 / 7 | 4 / 7 |
| serious Total, serious adverse events | 5 / 10 | 5 / 9 |
Outcome results
Primary
Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
Time frame: 4 weeks
Population: * Female breast cancer patients (Stage I-IIIC)~* Sedentary~* No previous history of anthracycline based chemotherapy~* Absence of heart disease~* Absence of contraindications for neoadjuvant chemotherapy~* Scheduled to receive neoadjuvant chemotherapy~* Primary attending oncologist approval~* English speaking~* Absence of contraindications for exercise stress testing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Individuals | Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. | 19 Participants |
Primary
Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection
Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.
Time frame: Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)
Population: Patients that withdrew, were lost to follow up, or developed treatment-induced contraindications to exercise testing, are not included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Eligible Individuals | Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection | -27.5 ml/kg/min | Standard Deviation 7.4 |
| Exercise | Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection | -1.0 ml/kg/min | Standard Deviation 13.2 |
Primary
Participant Adherence to the Exercise Intervention
Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.
Time frame: Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)
Population: The control group was not given heart rate monitors or an exercise prescription.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Participant Adherence to the Exercise Intervention | Introduction phase | 72.7 % exercise time at prescribed heart rate | Standard Error 11.5 |
| Exercise | Participant Adherence to the Exercise Intervention | Intermediate phase | 61.0 % exercise time at prescribed heart rate | Standard Error 5 |
| Exercise | Participant Adherence to the Exercise Intervention | Maintenance phase | 23.7 % exercise time at prescribed heart rate | Standard Error 7.1 |