Total Body Composition in Detection of Nutrition Depletio... | NCT02854735

Studies
Total Body Composition in Detection of Nutrition Depletion in Head and Neck Patients

NCT02854735

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 5, 2016Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Head and Neck Neoplasms
Dual-Energy X-Ray Absorptiometry
Malnutrition

Interventions

Imaging by CT and densitometry

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Aug 1, 2016

First Submission Date that Met QC Criteria

Aug 1, 2016

First Posted Date

Aug 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2016

Last Update Posted Date

Aug 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Head and neck neoplasm		Patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing CCRT	Other: Imaging by CT and densitometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imaging by CT and densitometry	Other	Imaging by CT and densitometry, no intervention involved	Head and neck neoplasm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alterations of the total body composition	Determine the alterations of total body composition in response to physiological change during the course of the cancer treatment, thus allowing clinicians to understand the optimal time for administering additional nutritional support during the CCRT treatment.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Comparison of densitometry with CT	To compare the performance of densitometry to CT in the evaluation of total body composition as a marker for monitoring cancer treatment related changes.	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy-proven head and neck (SCC), surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsy.
2010 7th edition AJCC stage III, IVA (T4N0-2) and IVB (any T, N3).
Well-informed and accepted treatment of CCRT.
Age 20-70 years old.
Negative pregnancy test for women of childbearing potential.
Adequate hematopoietic or organ function which is amenable for chemotherapy:
- A leukocyte count ≥3000/L
- Platelet count ≥100,000/L.
- Serum bilirubin level ≦ 1.5mg/dL
- Serum creatinine level ≦1.6 mg/dL or creatinine clearance ≥ 60 mL/min/1.73 m2.
- ALT/AST ≦ 3X ULN

9. Ability to understand and willingness to be enrolled in our study and sign a written informed consent document

Exclusion Criteria:

NPC is excluded from this study.
Patients have acute medical conditions (such as bacterial or viral infection or active cardiopulmonary disease) that may be incapable of having regular image study.
Patients are under regular steroid or hyperthyroid medications, which may have great impact on the whole body metabolism.
Patients are under-nutrient and they need to have regular liquid oral nutrition formulas support.
Patient that have dementia or pregnant.
Patients not expecting to comply with follow up.
Patient not suitable for chemotherapy.
Patient not suitable for MRI, such as claustrophobia, previous metal implantation, previous cardiac pacemaker implantation, inability to comply with MRI instructions and poor renal function.
Received barium study within a week.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing concurrent chemo-radiotherapy for cancer treatment

Sampling Method

Non-Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D010783	Photometry
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

ID	Term
D006258	Head and Neck Neoplasms
D044342	Malnutrition