Clinical trial NCT03280836: Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: Women In Steady Exercise Research - Neoadjuvant Exercise Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Physical Activity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: NRG Oncology
First posted: 2017-09-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to the intervention or control arm.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
timeFrame: 4 weeks
measure: Participant Adherence to the Exercise Intervention
timeFrame: Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)
measure: Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection
timeFrame: Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Assistant Professor, Penn State
name: Kathleen M Sturgeon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6.