RomTech Eisenberg Study

This study aims to assess use of the PortableConnect® to facilitate cardio-oncologic rehabilitation
in women following multimodal therapy for non-metastatic breast cancer. The PortableConnect®, a novel
delivery system for in-home tele-rehabilitation, has the potential to eliminate the barriers to compliance
with post-treatment exercise therapy in cancer patients.

Hypothesis
We hypothesize that use of the PortableConnect® will increase exercise therapy compliance in
women completing multimodal breast cancer treatment compared to a usual care cohort. We also expect
that early post-treatment exercise therapy will be safe and will improve quality of life and sleep quality,
and decrease fatigue.

Study Design
This is a single-center, prospective, randomized, non-blinded pilot study with an intent-to-treat
(ITT) analysis

Treatment Plan
Women who are successfully enrolled will be randomized into either the Exercise Arm where they will receive a PortableConnect device and monitoring through ROMTech's therapeutic monitoring system or the Control Arm. Women randomized to the Control Arm will receive clear verbal instructions of their expectations by the research study coordinator at the time they are informed of their randomization results. These participants will be encouraged to exercise on their own -- the current state.

Inclusion Criteria

  • female
  • any race/ethnicity
  • ages 30-79, inclusive
  • stages I-III primary breast cancer s/p completion of surgery plus chemotherapy (neoadjuvant
    or adjuvant) plus/minus radiation therapy [*Patients may complete the informed consent
    process before treatment completion but exercise therapy will not start until 2-12 weeks after
    the date of last treatment (either surgery, last dose of chemotherapy, or last day of radiation)]
  • able/willing to consent to participate

Exclusion Criteria

  • male
  • age <30 or ≥80
  • undergoing surgery alone or surgery plus radiotherapy as definitive therapy
  • pregnant women
  • metastatic disease (stage IV)
  • pacemaker or automated implantable cardioverter defibrillator (AICD)
  • myocardial infarction within 3 months of study enrollment
  • symptomatic cardiac disease of any type (e.g., chest pain, shortness of breath)
  • unstable angina
  • symptomatic heart failure (i.e., shortness of breath at rest or with exertion)
  • known uncontrolled hypertension (SBP>190 mmHg; DBP>95 mmHg)*
  • known resting O2 saturation of <92%*
  • uncontrolled arrhythmia causing symptoms or hemodynamic instability
  • any of the following within 3 months of study enrollment:
    • deep venous thrombosis
    • pneumonia
    • pulmonary embolism
    • syncope
  • moderate to severe symptomatic aortic stenosis
  • symptomatic asthma or COPD
  • pulmonary edema
  • in the opinion of the investigator, any additional active or acute medical illness that would
    interfere with the patient's ability to exercise
  • any uncontrolled musculoskeletal disease that would interfere with the patient's ability to
    exercise
  • cognitive impairment that would make the patient an unsafe candidate for the trial
  • any other condition or illness that in the opinion of the investigator, makes the patient an
    unsafe or poor candidate for the trial
  • unable/unwilling to consent to participate

Sponsor: ROMTech

Location: Hartford Hospital

Contact: Amanda Katzman (860-331-3721, amanda.katzman@hhchealth.org)

Cancer Clinical Research Office