Body Composition During Cancer Treatment (DuringSOZO)

December 9, 2023 updated by: Prisma Health-Upstate

Assessment of Body Composition During Cancer Treatment Using the SOZO Device

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received their first diagnosis of any type of cancer stage I-III. Patients must have received this diagnosis within 45 days of the Screening/Baseline study visit. Patients will be ideally enrolled prior to surgical cancer treatment, but enrollment post-surgery is allowable.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
During Cancer Treatment Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOZO device can detect changes in body composition
Time Frame: Up to 6 months
Assess change in body composition from baseline to final visit
Up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Collaborators

ImpediMed Limited

Investigators

  • Principal Investigator: Larry Gluck, MD, Prisma Health-Upstate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00077264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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