Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy (WISER-NET)

Penn State Health

Status: Completed

Conditions: Physical Activity; Breast Neoplasm

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03280836

5517

Details and patient eligibility

About

The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.

Full description

Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy

Enrollment: 19 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

3.1 Inclusion Criteria

• Women with a breast cancer diagnosis (Stage I-IIIC)
• Sedentary (< 75 min/wk of moderate intensity exercise over the past month)
• No previous history of anthracycline based chemotherapy
• Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
• Absence of contraindications for neoadjuvant chemotherapy
• Scheduled to receive neoadjuvant chemotherapy
• Primary attending oncologist approval

3.2 Exclusion Criteria

• Absolute contraindications for exercise stress testing

  • acute myocardial infarction (3-5 days)
  • unstable angina
  • uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  • syncope
  • acute endocarditis
  • acute myocarditis or pericarditis
  • uncontrolled heart failure
  • acute pulmonary embolus or pulmonary infarction
  • thrombosis of lower extremities
  • suspected dissecting aneurysm
  • uncontrolled asthma
  • pulmonary edema
  • room air desaturation at rest ≤85%
  • respiratory failure
  • acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
  • mental impairment leading to inability to cooperate
  • decisional impairment

• Non-English speaking

• Women only diagnosed with ductal carcinoma in situ

• Women diagnosed with stage 4 metastatic breast cancer

• Pregnant women

• Men

• Children

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Control

No Intervention group

Description:

We ask that participants in the control arm do not start an exercise program.

Exercise

Experimental group

Description:

Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence. Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.

Treatment:

Behavioral: Exercise