UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study of nutritional intervention period with elemental diet during concurrent chemoradiotherapy for head and neck cancer.
Title of the study (Brief title)	Pilot study of nutritional intervention period in concurrent chemoradiotherapy for head and neck cancer.
Region	Japan

Condition
Condition	Head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the importance of nutritional intervention period with elemental diet in the patient during concurrent chemoradiotherapy for head and neck cancer.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Change of nutritional status during chemoradiotherapy, serum rapid turnover protein and CRP
Key secondary outcomes	1)Physical examination, blood biochemistries 2)Adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Elemental diet (300kcal/day) administration in first and second course of chemoradiotherapy
Interventions/Control_2	Elemental diet (300kcal/day) administration in first course of chemoradiotherapy, and no administration in second course
Interventions/Control_3	No administration of elemental diet
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with head and neck cancer who will undergo radiotherapy. 2.Patient age at the time of obtaining informed consent is 20 years of age or older. 3.Written informed consent.
Key exclusion criteria	1.Past history of serious drug hypersensitivity. 2.Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment. 3.Abnormality in amino acid metabolism. 4.Pregnant or nursing women and those with the possibility of pregnancy. 5.Participation judged by physician to be inadvisable.
Target sample size	60

Research contact person
Name of lead principal investigator	Kiyoaki Tsukahara
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Otorhinoryngology, Head and Neck surgery
Address	1163 Tatemachi Hachioji-shi Tokyo
TEL	042-665-5611
Email	tsuka@tokyo-med.ac.jp

Public contact
Name of contact person	Kiyoaki Tsukahara
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Otorhinoryngology, Head and Neck surgery
Address	1163 Tatemachi Hachioji-shi Tokyo
TEL	042-665-5611
Homepage URL
Email	tsuka@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University Hachioji Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科大学八王子医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 28 Day
Anticipated trial start date	2013 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 31 Day
Last modified on	2016 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014885