Recruiting

HLI & PAI

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07474090

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Carcinoma

Breast Inflammatory Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Educational Intervention

Supportive Care

Biospecimen Collection

Magnetic Resonance Imaging

Study Details

Brief summary:

This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a healthy lifestyle during chemotherapy. The PAI in this study consists of virtual exercise sessions personalized to the needs of the patient, which may make it easier for patients to stay active during chemotherapy. HLI with PAI may be a more effective way to help maintain ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Breast Carcinoma

Breast Inflammatory Carcinoma

Study ID

NCT07474090

Start date

May 27, 2026

Status verified date

Jun, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \[if prior treatment received ≥ 2 years prior\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \[ER\], progesterone receptor \[PR\], human epidermal growth factor receptor 2 \[HER2\], etc.) are acceptable
  • Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy
  • Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group
  • Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report
  • Able to hold breath for 8 seconds
  • Must be able to read and understand English language
  • Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program
  • Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program
  • Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed

Exclusion Criteria:

  • At enrollment, the following diagnosis and/or conditions may not be present (i.e., documented in the medical record or by patient self-report):

  • Symptomatic claustrophobia
  • Pregnancy or breast-feeding
  • Ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders
  • Uncontrolled hypertension (systolic blood pressure > 190 mm Hg or diastolic blood pressure > 100 mm Hg)
  • Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician
  • Significant ventricular arrhythmias (> 20 premature ventricular contractions \[PVCs\]/min)
  • Atrial fibrillation with uncontrolled ventricular response (> 130 beats per minute \[bpm\])
  • Unstable or stable angina (cardiac chest pain)
  • Severe pulmonary hypertension
  • Left main coronary artery disease
  • Symptomatic heart failure
  • Severe valvular heart disease
  • Aortic aneurysm (> 45 mm diameter) or aortic dissection
  • Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
  • Hypertrophic obstructive cardiomyopathy
  • Acute myocardial infarction within 28 days of enrollment
  • Acute pulmonary embolus and/or deep vein thrombosis within 24 weeks prior to enrollment
  • Plans to relocate within 6 months of enrollment and unable to participate in study procedures
  • May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial
  • May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received ≥ 2 years prior)
  • May not be currently engaged in ≥ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 1 (PAI+HLI)

Within three weeks or less of chemotherapy start date, patients access the Trainerize app and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24 in the absence of unacceptable toxicity. Patients also receive a Fitbit device, resistance bands, and a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.

active comparator: Arm 2 (HLI)

Within three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.

Interventions

Exercise Intervention

Attend virtual personalized exercise sessions

Educational Intervention

Attend organized health workshops

Supportive Care

Receive Fitbit device, resistance bands, and/or loaner tablet

Biospecimen Collection

Undergo blood sample collection

Magnetic Resonance Imaging

Undergo CMR

Magnetic Resonance Imaging

Undergo ExeCMR

Questionnaire Administration

Ancillary studies

Accelerometry

Ancillary Studies

Electronic Health Record Review

Ancillary Studies

Cardiopulmonary Exercise Testing

Undergo CPET

Primary outcome measure

  • Peak oxygen consumption (VO2) [ Time Frame: At baseline and 24 weeks ]
  • Left ventricular ejection fraction (LVEF) [ Time Frame: At baseline and 24 weeks ]

Central Contacts and Locations

Central contacts

Karen Craver, MT, MHA

336-716-0891NCORP@wfusm.edu

Locations

Wake Forest NCORP RB

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Glenn Lesser, MD

336-716-0891ncorp@wfusm.edu

Karen Craver, MHA

336-716-0891ncorp@wfusm.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-15.