Clinical trial · Observational
Total Body Composition in Detection of Nutrition Depletion in Head and Neck Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dual-Energy X-Ray Absorptiometry | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging by CT and densitometry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Head and neck neoplasm
- description
- Patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing CCRT
- interventionNames
- Other: Imaging by CT and densitometry
Primary outcomes (1)
- measure
- Alterations of the total body composition
- timeFrame
- 3 years
- description
- 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.
Secondary outcomes (1)
- measure
- Comparison of densitometry with CT
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available