Status:
COMPLETED
Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Duke University
Conditions:
Breast Cancer
Eligibility:
FEMALE
45-80 years
Phase:
NA
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 the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01186367
Start Date
November 11 2010
End Date
May 17 2023
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065