Body Composition Post Cancer Treatment (PostSOZO)

Prisma Health-Upstate

Status: Completed

Conditions: Cancer

Treatments: Device: DEXA Scan; Device: SOZO Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03690401

Pro00077373

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 2 patient groups

Moving On Group

Description:

Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed before treatment and after completion of treatment. Moving On assessments will be performed at first and last study visits.

Treatment:

Device: SOZO Device

Device: DEXA Scan

Non-Moving On Group

Description:

Participants' body composition will be estimated using a SOZO device at 5 different time points over 12 weeks. Participant will also complete questionnaires and physical assessments during each study visit. These include waist \& hip measurements, weight/BMI, brief fatigue inventory, timed up and go test, 6 minute walk test, cancer distress assessment, ECOG performance status, hand grip strength test, and 3-day food diary. DEXA scans will be performed at first and last study visits.

Treatment:

Device: SOZO Device

Device: DEXA Scan