NCT02854735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

August 1, 2016

Last Update Submit

August 4, 2016

Conditions

Head and Neck NeoplasmsDual-Energy X-Ray AbsorptiometryMalnutrition

Keywords

Head and Neck NeoplasmsTotal body compositionDual-Energy X-Ray AbsorptiometryMalnutritionMuscle quantification

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Comparison of densitometry with CT

    3 years

Study Arms (1)

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

Imaging by CT and densitometryOTHER

Imaging by CT and densitometry, no intervention involved

Head and neck neoplasm

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Biopsy-proven head and neck (SCC), surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsy.
  • th 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
  • \. Ability to understand and willingness to be enrolled in our study and sign a written informed consent document

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsMalnutrition

Interventions

Densitometry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 3, 2016

Study Start

February 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

August 5, 2016

Record last verified: 2016-07

Locations

TW(1)