Body Composition Post Cancer Treatment
- Conditions
- Cancer
- Interventions
- Device: SOZO DeviceDevice: DEXA Scan
- Registration Number
- NCT03690401
- Lead Sponsor
- Prisma Health-Upstate
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Moving On Group SOZO Device 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. Non-Moving On Group DEXA Scan 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. Moving On Group DEXA Scan 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. Non-Moving On Group SOZO Device 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.
- Primary Outcome Measures
Name Time Method SOZO device can detect changes in body composition using SOZO measurements. 12 weeks Change from baseline in body composition measures (intracellular fluid, extracellular fluid, fat mass, fat free mass, skeletal muscle mass, phase angle, and hydration index)
- Secondary Outcome Measures
Name Time Method Correlate SOZO with food recall. 12 weeks Assess correlation of SOZO measurements with 3-day food recall.
Correlate SOZO with DEXA Scan 12 weeks Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results.
Detect changes in participant stress 12 weeks Change from baseline in Suscro Distress Inventory score
Correlate SOZO with urine test. 12 weeks Assess correlation of SOZO measurements with urine color test.
Detect changes in participant fatigue 12 weeks Change from baseline in Brief Fatigue Inventory score
Patient general health 12 weeks Evaluate patient general health using physical performance tests
Correlate SOZO with standard of care 12 weeks Assess correlation of SOZO measurements with standard of care measurements.
Trial Locations
- Locations (1)
Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship
🇺🇸Greenville, South Carolina, United States