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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009348
Receipt No. R000010980
Scientific Title Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Date of disclosure of the study information 2012/11/17
Last modified on 2015/09/11

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Basic information
Public title Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Acronym Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Scientific Title Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
Scientific Title:Acronym Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.
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 a correlation between the dosage of enteral nutrition formula and body weight reduction rate, and effect of nutritional supplement consumption for patients with head and neck cancer. To analyze a relationship between the change rate of each body composition factor and the adverse events as a secondary endpoint.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of change of body weight.
Dose of oral nutritional supplements per body weight.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 RACOL-NF Liquid for Enteral Use
Interventions/Control_2
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who will receive any one of the following 3 therapies: chemotherapy, radiation therapy, or chemoradiotherapy.
2.Patients who have been diagnosed and informed of diagnosis with head and neck cancer.
3.Patients who have been judged to be a candidate of oral intake by the investigator.
4.Patients aged 20 years old and older and 75 years old and under.
5.Patients and legal representative who have given voluntary written informed consent.
Key exclusion criteria 1.Patients who have a history of hypersensitivity to enteral nutritional supplements.
2.Patients with ileus.
3.Patients without an enteric function.
4.Patients with severe liver failure and/or renal failure.
5.Patients with abnormal glucose metabolism such as severe diabetes.
6.Patients with inborn error of amino acid metabolism.
7.Patients who had blood transfusion within one month.
8.Patients with active infection.
9.Patients with severe organ failure.
10.Patients who have edema at the time of registration.
11.Patients with electric implantable devices such as pacemakers.
12.Patients who are pregnant, suspected to be pregnant or breastfeeding.
13.Patients judged to be inappropriate for the study by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsuji
Organization Kanazawa Medical University
Division name Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address 1-1 Daigaku Uchinada Kahoku Ishikawa
TEL 076-286-2211
Email tsujih-i@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanako Teraguchi
Organization Kanazawa Medical University
Division name Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address 1-1 Daigaku Uchinada Kahoku Ishikawa
TEL 076-286-2211
Homepage URL
Email kanako-y@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2012 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 17 Day
Last modified on
2015 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010980

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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