Body Composition During Cancer Treatment

Completed

Brief Summary: The purpose of this study is to assess how bone density and body composition changes over a cancer patient's treatment via SOZO measurements, DEXA scan (bone density and whole body composition), performance status tests, food log, urine color test, and other study assessments. These assessments will begin after cancer diagnosis but prior to intervention, and continue during treatment and at post-treatment visits.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
During Cancer Treatment Group	DEXA Scan	Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.
During Cancer Treatment Group	SOZO Device	Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.

Primary Outcome Measures

Name	Time	Method
SOZO device can detect changes in body composition	Up to 6 months	Assess change in body composition from baseline to final visit

Secondary Outcome Measures

Name	Time	Method
Correlate SOZO with 24-hour food recall.	Up to 6 months	Assess correlation of SOZO measurements with 24-hour food recall.
Correlate SOZO with DEXA scan	Up to 6 months	Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results
Correlate SOZO with standard of care	Up to 6 months	Assess correlation of SOZO measurements with standard of care measurements
Detect changes in physical performance	Up to 6 months	Change from baseline in 6 minute walk test distance
Correlate SOZO with urine color test	Up to 6 months	Assess correlation of SOZO measurements with urine color test.

Locations (1): Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship
🇺🇸
Greenville, South Carolina, United States