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DuringSOZO: Body Composition During Cancer Treatment

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Recruiting
CT.gov ID
NCT03784911
Collaborator
ImpediMed Limited (Industry)
50
Enrollment
1
Location
51
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SOZO Device
  • Device: DEXA Scan

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Body Composition During Cancer Treatment Using the SOZO Device
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
During Cancer Treatment Group

Participants' body composition will be estimated using a SOZO device at 5 different time points across their cancer treatment. 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, cancer distress assessment, ECOG performance status, hand grip strength test, and 24-hour food recall. DEXA scans will be performed before treatment and after completion of treatment.

Device: SOZO 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. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants 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.

Device: DEXA Scan
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.

Outcome Measures

Primary Outcome Measures

  1. SOZO device can detect changes in body composition [Up to 6 months]

    Assess change in body composition from baseline to final visit

Secondary Outcome Measures

  1. Correlate SOZO with 24-hour food recall. [Up to 6 months]

    Assess correlation of SOZO measurements with 24-hour food recall.

  2. Correlate SOZO with DEXA scan [Up to 6 months]

    Assess correlation of SOZO measurements and DEXA scan (bone density with hip and spine measurements and whole body composition) results

  3. Correlate SOZO with standard of care [Up to 6 months]

    Assess correlation of SOZO measurements with standard of care measurements

  4. Detect changes in physical performance [Up to 6 months]

    Change from baseline in 6 minute walk test distance

  5. Correlate SOZO with urine color test [Up to 6 months]

    Assess correlation of SOZO measurements with urine color test.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship Greenville South Carolina United States 29605

Sponsors and Collaborators

  • Prisma Health-Upstate
  • ImpediMed Limited

Investigators

  • Principal Investigator: Larry Gluck, MD, Prisma Health-Upstate

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT03784911
Other Study ID Numbers:
  • Pro00077264
First Posted:
Dec 24, 2018
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prisma Health-Upstate
Body Composition
SOZO
Cancer
Cancer Treatment
Impedimed

Study Results

No Results Posted as of Jul 21, 2022