Body Composition During Cancer Treatment

NCT03784911 | Completed FDA Device

• 1 other identifier: Pro00077264
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Body Composition; SOZO; Cancer; Cancer Treatment; Impedimed

Outcome Measures

Primary Outcomes (1)

• SOZO device can detect changes in body composition

  Assess change in body composition from baseline to final visit

  Up to 6 months

Secondary Outcomes (5)

• Correlate SOZO with 24-hour food recall.

  Up to 6 months

• Correlate SOZO with DEXA scan

  Up to 6 months

• Correlate SOZO with standard of care

  Up to 6 months

• Detect changes in physical performance

  Up to 6 months

• Correlate SOZO with urine color test

  Up to 6 months

Study Arms (1)

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; Device: DEXA Scan

Interventions

SOZO Device 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.

During Cancer Treatment Group

DEXA Scan DEVICE

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.

During Cancer Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received their first diagnosis of any type of cancer stage I-III. Patients must have received this diagnosis within 45 days of the Screening/Baseline study visit. Patients will be ideally enrolled prior to surgical cancer treatment, but enrollment post-surgery is allowable.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• ImpediMed Limited: collaborator

Study Sites (1)

Prisma Health Cancer Institute Center for Integrative Oncology and Survivorship

Greenville, South Carolina, 29605, United States

Location

Related Publications (11)

• Churm 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 BACKGROUND

• Spiro 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 BACKGROUND

• Pacelli 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 BACKGROUND

• Bachmann 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 BACKGROUND

• Dewys 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 BACKGROUND

• Fearon 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 BACKGROUND

• Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

  PMID: 21296615 BACKGROUND

• Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.

  PMID: 19342610 BACKGROUND

• Strassmann G, Fong M, Kenney JS, Jacob CO. Evidence for the involvement of interleukin 6 in experimental cancer cachexia. J Clin Invest. 1992 May;89(5):1681-4. doi: 10.1172/JCI115767.

  PMID: 1569207 BACKGROUND

• Falconer JS, Fearon KC, Ross JA, Elton R, Wigmore SJ, Garden OJ, Carter DC. Acute-phase protein response and survival duration of patients with pancreatic cancer. Cancer. 1995 Apr 15;75(8):2077-82. doi: 10.1002/1097-0142(19950415)75:83.0.co;2-9.

  PMID: 7535184 BACKGROUND

• Terwee CB, Nieveen Van Dijkum EJ, Gouma DJ, Bakkevold KE, Klinkenbijl JH, Wade TP, van Wagensveld BA, Wong A, van der Meulen JH. Pooling of prognostic studies in cancer of the pancreatic head and periampullary region: the Triple-P study. Triple-P study group. Eur J Surg. 2000 Sep;166(9):706-12. doi: 10.1080/110241500750008466.

  PMID: 11034467 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Larry Gluck, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: December 24, 2018
• Study Start: October 1, 2018
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)