Clinical trial · Observational
Body Composition During Cancer Treatment
Assessment of Body Composition During Cancer Treatment Using the SOZO Device
NCT03784911CI-TRIAL-00081998DuringSOZOcompletedClinicalTrials.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 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.
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 (1)
- label
- During Cancer Treatment Group
- description
- 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.
- interventionNames
- Device: SOZO Device
- Device: DEXA Scan
Primary outcomes (1)
- measure
- SOZO device can detect changes in body composition
- timeFrame
- Up to 6 months
- description
- Assess change in body composition from baseline to final visit
Secondary outcomes (5)
- measure
- Correlate SOZO with 24-hour food recall.
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 * 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
References
Publications (11)
- BACKGROUNDChurm D, Andrew IM, Holden K, Hildreth AJ, Hawkins C. A questionnaire study of the approach to the anorexia-cachexia syndrome in patients with cancer by staff in a district general hospital. Support Care Cancer. 2009 May;17(5):503-7. doi: 10.1007/s00520-008-0486-1. Epub 2008 Jul 29. PMID 18663481
- BACKGROUNDSpiro A, Baldwin C, Patterson A, Thomas J, Andreyev HJ. The views and practice of oncologists towards nutritional support in patients receiving chemotherapy. Br J Cancer. 2006 Aug 21;95(4):431-4. doi: 10.1038/sj.bjc.6603280. Epub 2006 Aug 1. PMID 16880793
- BACKGROUNDPacelli F, Bossola M, Rosa F, Tortorelli AP, Papa V, Doglietto GB. Is malnutrition still a risk factor of postoperative complications in gastric cancer surgery? Clin Nutr. 2008 Jun;27(3):398-407. doi: 10.1016/j.clnu.2008.03.002. Epub 2008 Apr 23. PMID 18436350
- BACKGROUNDBachmann J, Heiligensetzer M, Krakowski-Roosen H, Buchler MW, Friess H, Martignoni ME. Cachexia worsens prognosis in patients with resectable pancreatic cancer. J Gastrointest Surg. 2008 Jul;12(7):1193-201. doi: 10.1007/s11605-008-0505-z. Epub 2008 Mar 18. PMID 18347879
- BACKGROUNDDewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3. PMID 7424938
- BACKGROUNDFearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345. PMID 16762946