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

Malnutrition Clinical Trial

— TBCHNC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854735
• Other study ID #: CMRPG2E0101
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 4, 2016
• Start date: February 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Biopsy-proven head and neck (SCC), surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsy.

2. 2010 7th edition AJCC stage III, IVA (T4N0-2) and IVB (any T, N3).

3. Well-informed and accepted treatment of CCRT.

4. Age 20-70 years old.

5. Negative pregnancy test for women of childbearing potential.

6. 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:

1. NPC is excluded from this study.

2. Patients have acute medical conditions (such as bacterial or viral infection or active cardiopulmonary disease) that may be incapable of having regular image study.

3. Patients are under regular steroid or hyperthyroid medications, which may have great impact on the whole body metabolism.

4. Patients are under-nutrient and they need to have regular liquid oral nutrition formulas support.

5. Patient that have dementia or pregnant.

6. Patients not expecting to comply with follow up.

7. Patient not suitable for chemotherapy.

8. 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.

9. Received barium study within a week.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Imaging by CT and densitometry
Imaging by CT and densitometry, no intervention involved

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Gueishan	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No