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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004738
Receipt No. R000005469
Scientific Title The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Date of disclosure of the study information 2010/12/16
Last modified on 2016/02/07

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Basic information
Public title The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Acronym The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Scientific Title The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Scientific Title:Acronym The effects of active nutritional support to patients with head and neck cancer during concurrent chemoradiotherapy
Region
Japan

Condition
Condition head and neck cancer(nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, supraglottic laryngeal carcinoma, cancers of the oral cavity)
Classification by specialty
Surgery in general Oto-rhino-laryngology Radiology
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effects on extent of weight loss, nutritional status, treatment completion rate and adverse event rate by supplementation of calculated nutritional energy intake during concurrent chemoradiotherapy for head and neck cancer.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Percent change of body weight loss during chemoradiotherapy
Key secondary outcomes 1)Physical examination, blood test
2)immune status index
3)treatment completion rate
4)occurrence of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 For the interventional group, daily nutritional energy will be calculated by multiplying the BEE by the activity factor (1.2) and the stress factor (1.5). The calculated energy will be administered basically by oral food intake during chemoradiotherapy, but the enteral feeding formula (RacolⓇ) will be supplied in the case of insufficient intake.
Interventions/Control_2 For the control group, daily nutritional energy will be calculated by multiplying the BEE by the activity factor (1.2) and the stress factor (1.1). The calculated energy will be administered basically by oral food intake during chemoradiotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)patients with head and neck cancer (nasopharyngeal carcinoma, oropharyngeal carcinoma, hypopharyngeal carcinoma, oral cavity carcinoma, supraglottic carcinoma)
2)clinical stage: II, III, IVA, IVB
3)PS=0, 1, 2
4)Leukocyte count>3,000/mm3
5)Platelet count>10x104/mm3
6)Hemoglobin>10g/dL
7)AST(GOT)<2.0 times the upper limit of normal at hospital
8)ALT(GPT)<2.0 times the upper limit of normal at hospital
9)Total bilirubin<3.0mg/dL
10)Creatinine<1.3mg/dL
11)Patients whose prognosis will be over 3 months
12)Patients who fully understand the study procedures and have given voluntary written informed consent after a full explanation is given
Key exclusion criteria 1)Patients with ileus
2)Patients with no residual intestinal function
3)Patients with severe liver disorder or renal disorder
4)Patients with abnormal glucose metabolism such as severe diabetes mellitus : HbA1c > 7.0%
5)Patients with congenital disorders of amino acid metabolism
6)Patients with allergy to any ingredient of milk
7)Patients with electrolyte metabolism
8)Patients with hemophilia
9)Patients who were given a blood transfusion within 1 month
10)Pregnant women, women suspected of being pregnant, or lactating women
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunitoshi Yoshino
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Uemura, Susumu Nakahara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL 06-6972-1181
Homepage URL
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪府立成人病センター(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 05 Month 01 Day
Date analysis concluded
2015 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 16 Day
Last modified on
2016 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005469

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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