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

August 4, 2016 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taoyuan
      • Gueishan, Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung memorial hospital
        • Contact:
        • Sub-Investigator:
          • Yu-Hsiang Juan
        • Sub-Investigator:
          • Kun-Yun Yeh
        • Sub-Investigator:
          • Cheng-Hsu Wang
        • Sub-Investigator:
          • Fang-Ping Chen
        • Sub-Investigator:
          • Jen-Seng Huang
        • Sub-Investigator:
          • Chien-Hung Lai
        • Sub-Investigator:
          • Tsung-Han Wu
        • Sub-Investigator:
          • Pei-Hung Chang
        • Sub-Investigator:
          • Yan-Min Huang
        • Sub-Investigator:
          • Hue-Fang Hsuen
        • Sub-Investigator:
          • Koon-Kwan Ng
        • Sub-Investigator:
          • Shu-Hang Ng
        • Sub-Investigator:
          • Chih-Ming Fang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Imaging by CT and densitometry, no intervention involved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alterations of the total body composition
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of densitometry with CT
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG2E0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on IRB regulation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Neoplasms

Clinical Trials on Imaging by CT and densitometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe