Cancer Clinical Trial
— PostSOZOOfficial title:
Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device
Verified date | November 2023 |
Source | Prisma Health-Upstate |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Prisma Health-Upstate | ImpediMed Limited |
United States,
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
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 |
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