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All-extremity Exercise During Breast Cancer Chemotherapy

All-extremity Exercise as a Novel Strategy for Optimizing Cardiovascular Function During Chemotherapy for Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether exercise using both arms and legs can help protect the heart and blood vessels during breast cancer chemotherapy. It is for women ages 18 to 85 with stage I–III breast cancer that has not spread to distant parts of the body.

Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–III invasive breast cancer, which has grown into nearby breast tissue but has not spread to distant body parts.
  • Be female and 18 to 85 years old.
  • Be scheduled to start chemotherapy before or after surgery with an anthracycline, alkylating agent, or taxane drug.
  • Have no health reason that makes exercise unsafe.
  • Have approval from the study clinician.
  • Be able to give informed consent, sign the consent form, and agree to follow study steps.

Who can't join

  • Do not meet all the requirements to join.
  • Are receiving targeted cancer drugs called CDK4/6 or PARP inhibitors.
  • Are receiving radiation therapy at the same time as chemotherapy.
  • Have stage 2 or higher lymphedema before joining—a condition that causes swelling from fluid buildup.
  • Have certain heart or blood vessel conditions or past treatments, such as stroke, heart failure, heart attack, heart-related chest pain, heart bypass surgery, or a procedure to open a heart artery or place a stent. This also includes low blood flow to the heart during an exercise test.
  • Are in another experimental treatment program that could affect the study results, such as a weight-loss diet study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III * Female * 18 to 85 years of age * Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane) * Absence of contraindications to exercise * Study clinician approval * Able to give consent * Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process Exclusion Criteria: * Do not meet inclusion criteria * Receiving targeted therapies (CDK4/6 or PARP inhibitors) * Receiving radiation therapy concurrent with chemotherapy * Lymphedema stage ≥ 2 prior to study enrollment * Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent) * Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

Study sites (1)

FL