Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 9:07 PM
Study NCT ID:
NCT02854735
Status:
UNKNOWN
Last Update Posted:
2016-08-05
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Body Composition in Detection of Nutrition Depletion in Head and Neck Patients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Non-invasive Total Body Composition in Early Detection of Nutrition Depletion, Changes in Body Physiology and Treatment Response in Head and Neck Patients Undergoing Concurrent Chemoradiotherapy
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TBCHNC
Brief Summary:
The purpose of this study is to define the role of total body composition in the guidance of nutritional support and treatment monitoring in head and neck patients. Furthermore, the second aim of this study is to compare the clinical performance of dual energy X-ray absorptiometry as compared to CT in evaluating total body composition of patients.
Detailed Description:
In this 4-year cohort study, a total of 120 patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing concurrent chemo-radiotherapy will be enrolled. Laboratory examination will be performed to evaluate the physiological change and treatment related toxicity, including BUN and Cr for hydration and renal function; complete blood cell and differential count, pre-albumin and albumin for nutrition, and C-reactive protein for inflammatory change. Both CT and dual energy X-ray absorptiometry (DXA) will be used to evaluate total body composition. CT is used to evaluate surface area of fat and muscle, and DXA is used to evaluate lean body mass, fat body mass and bone mineral content. MRI of the head and neck region is used for tumor staging of the head and neck cancer, monitoring the treatment response and detecting treatment related adverse effect.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: