Cancer Clinical Trial
— DuringSOZOOfficial title:
Assessment of Body Composition During Cancer Treatment Using the SOZO Device
Verified date | July 2022 |
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 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.
Status | Completed |
Enrollment | 51 |
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 - 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 |
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,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SOZO device can detect changes in body composition | Assess change in body composition from baseline to final visit | Up to 6 months | |
Secondary | Correlate SOZO with 24-hour food recall. | Assess correlation of SOZO measurements with 24-hour food recall. | Up to 6 months | |
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 | Up to 6 months | |
Secondary | Correlate SOZO with standard of care | Assess correlation of SOZO measurements with standard of care measurements | Up to 6 months | |
Secondary | Detect changes in physical performance | Change from baseline in 6 minute walk test distance | Up to 6 months | |
Secondary | Correlate SOZO with urine color test | Assess correlation of SOZO measurements with urine color test. | Up to 6 months |
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