Body Composition During Cancer Treatment

NCT03784911 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2024-10-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

SOZO Device

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.

DEVICE

DEXA Scan

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.

Sponsors & Collaborators

  • ImpediMed Limited

    collaborator INDUSTRY
  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Larry Gluck, MD · Prisma Health-Upstate

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-11-15
Completion
2023-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784911 on ClinicalTrials.gov