CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
SOZO Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03784911
NCT03784911N/ACompleted

Assessment of Body Composition During Cancer Treatment Using the SOZO Device

Prisma Health-Upstate·observational·Posted Dec 24, 2018·Updated Oct 28, 2024

In Brief

An observational study evaluating SOZO Device and DEXA Scan for Cancer. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States
CollaboratorsImpediMed Limited

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 24, 2018
Enrollment StartOct 1, 2018
Primary CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.5 years ago

Interventions

SOZO Devicedevice

SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes.

DEXA Scandevice

DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.