Phase
Condition
Ductal Carcinoma In Situ (Dcis)
Treatment
Aerobic Training
Clinical Study ID
Ages 21-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 21-80 years
Female
Surgically resected early stage (I-III) primary breast cancer
Post-menopausal, defined as one of the following:
Age ≥ 45 with no menses for at least 2 years
Chemically and/or surgically induced menopause through ovarian suppression, asdetermined by the primary oncologist
Estradiol level of ≤30 pg/mL
An interval of at least one year, but no more than five years, following the fullcompletion of definitive therapy for malignant disease. Definitive therapy isdefined as:
Surgery plus radiation
Surgery plus chemotherapy
Surgery plus trastuzumab
Exercise intolerance (i.e., patients must have a VO2peak below the predicted foractive age and sex-matched individuals. (+/- the technical error of 1.32mL/kg/min)].
Note: Normative values are available up to 80 years of age)
Able to complete an acceptable baseline CPET, in the absence of high-risk ECGfindings or other inappropriate response to exercise as determined by the PI, asdefined by any of the following criteria:
Achieving a plateau in oxygen consumption, concurrent with an increase in poweroutput;
A respiratory exchange ratio ≥ 1.10;
Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm ofage-predicted HRmax [HRmax = 220-Age[years]);
Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18on the BORG scale
Willingness to comply with all study-related procedures.
Exclusion
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 plannedstudy procedures
Thrombosis of lower extremities
Suspected dissecting aneurysm
Uncontrolled asthma
Pulmonary edema
Respiratory failure
Acute non-cardiopulmonary disorders that may affect exercise performance or beaggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)
Presence of any other concurrent, actively treated malignancy
History of any other malignancy treated within the past 3 years (other thannon-melanoma skin cancer)
Presence of distant metastatic disease (i.e., stage IV)
Room air desaturation at rest ≤ 85%
Mental impairment leading to inability to cooperate.
Any other condition or intercurrent illness that, in the opinion of theinvestigator, makes the participant a poor candidate for the trial.
Study Design
Study Description
Connect with a study center
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
Hartford, Connecticut 06102
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting

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