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New treatment option for Breast Cancer
Official title Study of Aerobic Training for People Receiving Treatment for Breast Cancer
ClinicalTrials.gov ID: NCT05716893
What this study is testing
- What it's testing
- In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Aged ≥18 years
- Female
- Diagnosed with primary breast cancer as defined by one of the following:
- Histological confirmation
- As per standard of care imaging
You likely can't join if
- Enrollment onto any other treatment investigational study, except interventions determined by the PI not to confound study outcomes
- Receiving treatment for any other diagnosis of invasive cancer
- Distant metastatic malignancy of any kind
- Mental impairment leading to inability to cooperate
- Any of the following contraindications to cardiopulmonary exercise testing: i. Acute myocardial infarction within 3-5 days of any planned study...
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
See the full eligibility criteria
- Aged ≥18 years
- Female
- Diagnosed with primary breast cancer as defined by one of the following:
- Histological confirmation
- As per standard of care imaging
- Scheduled to receive neoadjuvant/adjuvant systemic and/or locoregional therapy
- Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report
- Willingness to comply with all study-related procedures
- 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.
- Enrollment onto any other treatment investigational study, except interventions determined by the PI not to confound study outcomes
- Receiving treatment for any other diagnosis of invasive cancer
- Distant metastatic malignancy of any kind
- Mental impairment leading to inability to cooperate
- Any of the following contraindications to cardiopulmonary exercise testing: i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing...
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.