Breast Cancer
Conditions
Keywords
breast cancer, Linear Versus Nonlinear Aerobic Training, 15-147
Brief summary
The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.
Interventions
BEHAVIORALLinear Aerobic Training
The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
BEHAVIORALNonlinear Aerobic Training
The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
BEHAVIORALProgressive Stretching
All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
OTHERBlood draws
Complete blood count
Sponsors
Duke University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 45-80 years * Female * Has been diagnosed with early-stage breast cancer * Post-menopausal, defined as : * Age ≥ 45 with no menses for at least 2 years * Chemically induced menopause through ovarian suppression, as determined by the primary oncologist * An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease. Primary therapy is defined as: * Surgery plus radiation * Surgery plus chemotherapy * Surgery plus trastuzumab * Surgery plus hormone therapy Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date. Patients who are currently receiving hormone therapy are eligible for enrollment. * Weight of \< 205 kgs * ECOG status of 0 or 1 * Life expectancy ≥ 6 months * Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week. * Exercise intolerance defined by a VO2peak below that predicted for sedentary age and sex-matched individuals as defined in Appendix H. * Willing to be randomized to one of the study arms * Able to complete an acceptable baseline CPET, in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator. * Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: * Achieving a plateau in oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.10; * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
Exclusion criteria
* Any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction within 3-5 days of any planned study procedures; * Unstable angina; * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; * Recurrent syncope; * Active endocarditis; * Acute myocarditis or pericarditis; * Symptomatic severe aortic stenosis; * Uncontrolled heart failure; * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures * Thrombosis of lower extremities; * Suspected dissecting aneurysm; * Uncontrolled asthma; * Pulmonary edema; * Respiratory failure; * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); * Presence of any other concurrent, actively treated malignancy * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer) * Presence of metastatic disease * Room air desaturation at rest ≤ 85% * Mental impairment leading to inability to cooperate * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | Baseline | VO2 or peak oxygen consumption will be measured at Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Linear Aerobic Training The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training: The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count | 58 |
| Nonlinear Aerobic Training The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Nonlinear Aerobic Training: The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count | 59 |
| Progressive Stretching Group (Attention Control) The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching: All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)
Blood draws: Complete blood count | 57 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not receive study treatment | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 4 | 7 |
Baseline characteristics
| Characteristic | Linear Aerobic Training | Total | Progressive Stretching Group (Attention Control) | Nonlinear Aerobic Training |
|---|---|---|---|---|
| Age, Continuous | 59 years | 58 years | 58 years | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 149 Participants | 48 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 20 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 35 Participants | 12 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 19 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) White | 38 Participants | 115 Participants | 37 Participants | 40 Participants |
| Region of Enrollment United States | 58 Participants | 174 Participants | 57 Participants | 59 Participants |
| Sex: Female, Male Female | 58 Participants | 174 Participants | 57 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 59 | 1 / 57 |
| other Total, other adverse events | 58 / 58 | 59 / 59 | 8 / 57 |
| serious Total, serious adverse events | 0 / 58 | 0 / 59 | 0 / 57 |
Outcome results
Primary
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
VO2 or peak oxygen consumption will be measured at Baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Linear Aerobic Training | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 21.5 mL/kg/min | Standard Deviation 4.4 |
| Nonlinear Aerobic Training | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 22.2 mL/kg/min | Standard Deviation 4.3 |
| Progressive Stretching Group (Attention Control) | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 21.8 mL/kg/min | Standard Deviation 3.8 |
Primary
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)
Time frame: 8 weeks
Population: Only nonlinear aerobic training measured at 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nonlinear Aerobic Training | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 22.6 mL/kg/min | Standard Deviation 4.5 |
Primary
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).
Time frame: 16 weeks
Population: Nonlinear aerobic training measured at 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Linear Aerobic Training | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 22.2 mL/kg/min | Standard Deviation 4.6 |
| Nonlinear Aerobic Training | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 23.1 mL/kg/min | Standard Deviation 4.8 |
| Progressive Stretching Group (Attention Control) | To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. | 21.8 mL/kg/min | Standard Deviation 3.7 |