Clinical trial · Observational
Body Composition Post Cancer Treatment
Assessment of Body Composition in Cancer Patients Post-Treatment Using the SOZO Device
NCT03690401CI-TRIAL-00082006PostSOZOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEXA Scan | Device | — | UNRESOLVED |
| SOZO Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Device: SOZO Device
- Device: DEXA Scan
- label
- 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.
- interventionNames
- Device: SOZO Device
- Device: DEXA Scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDMayer 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
- BACKGROUNDJacobs 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