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New treatment option for Early Stage Breast Cancer
Official title Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
ClinicalTrials.gov ID: NCT04458532
What this study is testing
- What it's testing
- This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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, as determined 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 full completion of definitive therapy for malignant disease. Definitive therapy is defined as:
- Surgery plus radiation
- Surgery plus chemotherapy
- Surgery plus trastuzumab
- Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)]. Note: Normative values are available up to 80 years...
- 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 PI, 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
- Willingness to comply with all study-related procedures.
- 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 (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 than non-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 the investigator, makes the participant a poor candidate for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hartford, Connecticut, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.