Clinical trial NCT03690401: Body Composition Post Cancer Treatment
Official title: Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Post-Treatment
Body Composition
SOZO
Impedimed
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: ImpediMed Limited
First posted: 2018-10-01
Enrollment: 52
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: The study population will include patients who received their first diagnosis of most cancer types stage I-III. Patients must have recently completed their cancer treatment and be eligible to participate in the Moving On program, although patient will be eligible to participation in this study regardless of willingness to participate in the Moving On program. Non-Moving On program participants must constitute ≥ 10 and ≤ 25 of the overall enrolled patient population to ensure adequate controls are in place.

Brief summary: 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.

Detailed description: 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.

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
* 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

Primary outcomes:
measure: SOZO device can detect changes in body composition using SOZO measurements.
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient general health
timeFrame: 12 weeks
measure: Correlate SOZO with food recall.
timeFrame: 12 weeks
measure: Correlate SOZO with DEXA Scan
timeFrame: 12 weeks
measure: Correlate SOZO with standard of care
timeFrame: 12 weeks
measure: Detect changes in participant fatigue
timeFrame: 12 weeks
measure: Detect changes in participant stress
timeFrame: 12 weeks
measure: Correlate SOZO with urine test.
timeFrame: 12 weeks
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
name: Larry Gluck, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.