Status:
COMPLETED
Body Composition During Cancer Treatment
Lead Sponsor:
Prisma Health-Upstate
Collaborating Sponsors:
ImpediMed Limited
Conditions:
Cancer
Eligibility:
All Genders
18+ years
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), perfo...
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03784911
Start Date
October 1 2018
End Date
November 15 2023
Last Update
October 28 2024
Active Locations (1)
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1
Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship
Greenville, South Carolina, United States, 29605