Body Composition Post Cancer Treatment

Cancer Clinical Trial

— PostSOZO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690401
• Other study ID #: Pro00077373
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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
• 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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	ImpediMed Limited

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient general health	Evaluate patient general health using physical performance tests	12 weeks
Secondary	Correlate SOZO with food recall.	Assess correlation of SOZO measurements with 3-day food recall.	12 weeks
Secondary	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
Secondary	Correlate SOZO with standard of care	Assess correlation of SOZO measurements with standard of care measurements.	12 weeks
Secondary	Detect changes in participant fatigue	Change from baseline in Brief Fatigue Inventory score	12 weeks
Secondary	Detect changes in participant stress	Change from baseline in Suscro Distress Inventory score	12 weeks
Secondary	Correlate SOZO with urine test.	Assess correlation of SOZO measurements with urine color test.	12 weeks