Early Stage Breast Cancer study: Aerobic Training
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
- The study aims to find out how different lengths and durations of aerobic exercise impact how well the body uses oxygen, heart pumping, lung function, and blood vessel health.
- Who it's for
- Post-menopausal women who have completed treatment for early stage breast cancer.
- What's involved
- Participants will follow a specific aerobic exercise program, which involves light-to-moderate physical activity using large muscle groups for at least 10 minutes per session.
- Time commitment
- The study involves participating in exercise sessions over a period of several weeks, though the exact total duration is not specified in the text.
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
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Aged 21-80 years
- Female
- Surgically resected early stage (I-III) primary breast cancer
- 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
- 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)].
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Hartford, Connecticut, United States; New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.