Clinical trial NCT03784911: Body Composition During Cancer Treatment
Official title: Assessment of Body Composition During Cancer Treatment Using the SOZO Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Body Composition
SOZO
Cancer
Cancer Treatment
Impedimed
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: ImpediMed Limited
First posted: 2018-12-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received their first diagnosis of any type of cancer stage I-III. Patients must have received this diagnosis within 45 days of the Screening/Baseline study visit. Patients will be ideally enrolled prior to surgical cancer treatment, but enrollment post-surgery is allowable.

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: SOZO device can detect changes in body composition
timeFrame: Up to 6 months
Secondary outcomes:
measure: Correlate SOZO with 24-hour food recall.
timeFrame: Up to 6 months
measure: Correlate SOZO with DEXA scan
timeFrame: Up to 6 months
measure: Correlate SOZO with standard of care
timeFrame: Up to 6 months
measure: Detect changes in physical performance
timeFrame: Up to 6 months
measure: Correlate SOZO with urine color test
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Larry Gluck, MD
role: PRINCIPAL_INVESTIGATOR
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