Head and Neck NeoplasmsTBCHNCNCT02854735
Total Body Composition in Detection of Nutrition Depletion in Head and Neck Patients
An observational study of Head and Neck Neoplasms and Dual-Energy X-Ray Absorptiometry, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Head and Neck Neoplasms, Dual-Energy X-Ray Absorptiometry, Malnutrition
- What is being tested?
- Imaging by CT and densitometry
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing concurrent chemo-radiotherapy for cancer treatment
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
Yu-Ching Lin, MD, +886-9-75366386, yuching1221@gmail.com
Yu-Ching Lin
About this study
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
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.
Read the 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.
- Being tested
- Imaging by CT and densitometry
- Keywords
- Head and Neck Neoplasms, Total body composition, Dual-Energy X-Ray Absorptiometry, Malnutrition, Muscle quantification
- Medical subject headings
- Head and Neck Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging by CT and densitometryOther
Imaging by CT and densitometry, no intervention involved
| Study group | Role | What they receive |
|---|---|---|
| Head and neck neoplasm | Patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing CCRT Receives: Other: Imaging by CT and densitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854735
- Sponsor's protocol ID
- CMRPG2E0101
- Acronym
- TBCHNC
- Status last verified
- Jul 2016
- First submitted
- 1 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Depending on IRB regulation
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02854735
- Acronym / sponsor ID
- TBCHNC / CMRPG2E0101
- Keywords
- Head and Neck Neoplasms, Total body composition, Dual-Energy X-Ray Absorptiometry, Malnutrition, Muscle quantification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck neoplasm | – | Other: Imaging by CT and densitometryPatients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing CCRT |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage III-IV head and neck cancer (squamous cell carcinoma) patient undergoing concurrent chemo-radiotherapy for cancer treatment
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging by CT and densitometryImaging by CT and densitometry, no intervention involved | Other | Head and neck neoplasm |
Primary outcome
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.
1 secondary outcome
Comparison of densitometry with CT
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: Undecided. Depending on IRB regulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Dual-Energy X-Ray Absorptiometry, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations of the total body composition (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.