Greenville, South Carolina 29605


Purpose:

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.


Study summary:

This is an observational, prospective device use study. 50 subjects will be enrolled in the study. The study will look at the changes in the participants body composition as they go through 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 the course of their cancer treatment where SOZO measurements will be taken as well as other study measurements.


Criteria:

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


NCT ID:

NCT03784911


Primary Contact:

Principal Investigator
Larry Gluck, MD
Greenville Health System

Armand DeSollar, BS
Phone: 864-455-6251
Email: adesollar@ghs.org


Backup Contact:

Email: molinger2@ghs.org
Matt Olinger, BS
Phone: 864-455-5119


Location Contact:

Greenville, South Carolina 29605
United States

Armand DeSollar, BS
Phone: 864-455-6251
Email: adesollar@ghs.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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