Body Composition Post Cancer Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | October 1, 2018 |
| End Date: | October 2019 |
| Contact: | Armand DeSollar, BS |
| Email: | adesollar@ghs.org |
| Phone: | 864-455-6251 |
Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device
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.
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.
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.
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.
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
We found this trial at
1
site
Greenville, South Carolina 29605
Phone: 864-455-6251
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