Body Composition Post Cancer Treatment

NCT03690401 | Completed FDA Device

• 1 other identifier: Pro00077373
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Post-Treatment; Body Composition; SOZO; Impedimed

Outcome Measures

Primary Outcomes (1)

• SOZO device can detect changes in body composition using SOZO measurements.

  Change from baseline in body composition measures (intracellular fluid, extracellular fluid, fat mass, fat free mass, skeletal muscle mass, phase angle, and hydration index)

  12 weeks

Secondary Outcomes (7)

• Patient general health

  12 weeks

• Correlate SOZO with food recall.

  12 weeks

• Correlate SOZO with DEXA Scan

  12 weeks

• Correlate SOZO with standard of care

  12 weeks

• Detect changes in participant fatigue

  12 weeks

Study Arms (2)

Moving On Group

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.

Device: SOZO Device; Device: DEXA Scan

Non-Moving On Group

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.

Device: SOZO Device; Device: DEXA Scan

Interventions

SOZO Device DEVICE

SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. Participants will be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes. A total of 5 SOZO measurements will be recorded over 12 weeks.

Moving On Group; Non-Moving On Group

DEXA Scan DEVICE

DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.

Moving On Group; Non-Moving On Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• ImpediMed Limited: collaborator

Study Sites (1)

Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship

Greenville, South Carolina, 29605, United States

Location

Related Publications (2)

• 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.

  PMID: 28049573 BACKGROUND

• 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.

  PMID: 28049574 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Larry Gluck, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: October 1, 2018
• Study Start: October 1, 2018
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)