Body Composition Post Cancer Treatment

Last updated: October 24, 2024
Sponsor: Prisma Health-Upstate
Overall Status: Completed

Phase

N/A

Condition

Cancer

Treatment

DEXA Scan

SOZO Device

Clinical Study ID

NCT03690401
Pro00077373
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/Baselinevisit

Exclusion

Exclusion Criteria:

  • Active implanted medical device (cardiac pacemakers, defibrillators) or connected toelectronic life support devices or patients with other metallic devices that wouldinterfere with BIS measurements

  • Amputees

  • Any acute swelling condition diagnosed or actively being treated within 30 days ofscreening/baseline (including, but not limited to: acute heart failure, renaldisease 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 projectedenrollment. 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

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: DEXA Scan
Phase:
Study Start date:
October 01, 2018
Estimated Completion Date:
November 15, 2023

Study 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.

Connect with a study center

  • Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship

    Greenville, South Carolina 29605
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.