Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prisma Health-Upstate
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- SOZO device can detect changes in body composition using SOZO measurements.
Study Overview
Brief Summary
The purpose of this study is to assess how bone density and body composition changes after a cancer patient completes treatment and through 12-weeks post-treatment. Patients who enroll in the 12-week exercise program, Moving On, and those that do not elect to participate in the Moving On program will both be tracked, with assessments including SOZO measurements, DEXA scan (bone density and whole body composition), performance status tests, food log, urine color test, and other study assessments.
Detailed Description
This is an observational, prospective, parallel-arm device use study. 50 subjects will be enrolled in the study. The study will look at the changes in the participants body composition post 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 12 weeks where SOZO measurements will be taken as well as other study measurements.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Recent diagnosis of first cancer stage I-III
- •Completion of final primary cancer treatment within 6 months of Screening/Baseline visit
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
- •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
- •Patients with head or neck 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
Outcomes
Primary Outcomes
SOZO device can detect changes in body composition using SOZO measurements.
Time Frame: 12 weeks
Change from baseline in body composition measures (intracellular fluid, extracellular fluid, fat mass, fat free mass, skeletal muscle mass, phase angle, and hydration index)
Secondary Outcomes
- Correlate SOZO with food recall.(12 weeks)
- Correlate SOZO with DEXA Scan(12 weeks)
- Detect changes in participant stress(12 weeks)
- Correlate SOZO with urine test.(12 weeks)
- Detect changes in participant fatigue(12 weeks)
- Patient general health(12 weeks)
- Correlate SOZO with standard of care(12 weeks)