Body Composition During Cancer Treatment

This is an observational, prospective device use study. 50 subjects will be enrolled in the
study. The study will look at the changes in the participants body composition as they go
through cancer treatment using the SOZO device. The SOZO device is intended to estimate the
following body composition parameters: Fluid status (TBW, ECF, ICF), Total body composition
(fat free mass, fat mass, % of weight), Metabolic report (active tissue mass, extracellular
mass, basal metabolic rate), Skeletal muscle mass, Phase angle, Body mass index (BMI),
Weight, and Hydration index (Hy-Dex) analysis. Participants will have 5 study visits during
the course of their cancer treatment where SOZO measurements will be taken as well as other
study measurements.

Inclusion Criteria:

- Willingness and ability to provide consent

- Mentally and physically able to comply with protocol

- Age 18 and over

- Body Mass Index (BMI) ≤ 40 or body weight of <300 pounds

- Received first cancer diagnosis within 45 days of the Screening/Baseline study visit

- Diagnosis of cancer stage I-III

- Attempts to remove the cancer via chemotherapy, immunotherapy, radiation, etc. have
not been initiated. Subjects will ideally enroll prior to any surgical cancer
treatment, but enrollment post-surgery is allowable (capped at 15 subjects)

- Planned chemotherapy treatment not to exceed 6 months adjuvant treatment. Planned
radiation and/or surgery, as well as planned maintenance therapy is allowable (i.e.
continued treatment with endocrine therapy, monoclonal antibodies, or other
longer-term treatments with minimal side effects) as determined by PI and approved by
sponsor.

Exclusion Criteria:

- Active implanted medical device (cardiac pacemakers, defibrillators) or connected to
electronic life support devices or patients with other metallic devices that would
interfere with BIS measurements

- Amputees

- Any acute swelling condition diagnosed or actively being treated within 30 days of
screening/baseline (including, but not limited to: acute heart failure, renal disease
with dialysis, pulmonary edema, thrombophlebitis, deep vein thrombosis, pleural
effusion, ascites, pregnancy)

- Patients with basal cell carcinoma or squamous cell skin cancer

- Currently suffering from uncontrolled intercurrent illness, including: ongoing/active
infection, unstable angina pectoris, or cardiac arrhythmia

- Enrollment of female breast cancer patients not to exceed 60% of total projected
enrollment. Once this threshold has been reached, these subjects will be excluded

- Planned orthopedic implant surgery

- Planned breast implant surgery

- Presence of or plan for breast expanders post-mastectomy

- Dependent upon transfusions

- Any history of organ transplant

- Presence of colostomy/ostomy