Body Composition Post Cancer Treatment (PostSOZO)

Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: DEXA Scan; Device: SOZO Device

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients who received their first diagnosis of most cancer types stage I-III. Patients must have recently completed their cancer treatment and be eligible to participate in the Moving On program, although patient will be eligible to participation in this study regardless of willingness to participate in the Moving On program. Non-Moving On program participants must constitute ≥ 10 and ≤ 25 of the overall enrolled patient population to ensure adequate controls are in place.

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
• 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
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moving On Group; Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. 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, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed before treatment and after completion of treatment. Moving On assessments will be performed at first and last study visits.	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.; 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. Participants will 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. A total of 5 SOZO measurements will be recorded over 12 weeks.
Non-Moving On Group; Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. 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, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed at first and last study visits.	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.; 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. Participants will 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. A total of 5 SOZO measurements will be recorded over 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOZO device can detect changes in body composition using SOZO measurements.	Change from baseline in body composition measures (intracellular fluid, extracellular fluid, fat mass, fat free mass, skeletal muscle mass, phase angle, and hydration index)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient general health	Evaluate patient general health using physical performance tests	12 weeks
Correlate SOZO with food recall.	Assess correlation of SOZO measurements with 3-day food recall.	12 weeks
Correlate SOZO with DEXA Scan	Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results.	12 weeks
Correlate SOZO with standard of care	Assess correlation of SOZO measurements with standard of care measurements.	12 weeks
Detect changes in participant fatigue	Change from baseline in Brief Fatigue Inventory score	12 weeks
Detect changes in participant stress	Change from baseline in Suscro Distress Inventory score	12 weeks
Correlate SOZO with urine test.	Assess correlation of SOZO measurements with urine color test.	12 weeks

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: ImpediMed Limited
• Investigators: Principal Investigator: Larry Gluck, MD, Prisma Health

Publications and helpful links

General Publications

• Mayer DK, Nasso SF, Earp JA. Defining cancer survivors, their needs, and perspectives on survivorship health care in the USA. Lancet Oncol. 2017 Jan;18(1):e11-e18. doi: 10.1016/S1470-2045(16)30573-3.
• Jacobs LA, Shulman LN. Follow-up care of cancer survivors: challenges and solutions. Lancet Oncol. 2017 Jan;18(1):e19-e29. doi: 10.1016/S1470-2045(16)30386-2.

Study record dates

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 10, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Body Composition; SOZO; Impedimed; Post-Treatment
• Other Study ID Numbers: Pro00077373

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: Yes
• product manufactured in and exported from the U.S.: No