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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006461
Receipt No. R000007239
Scientific Title Open Label Study of Hangeshashinto for Prevention of Chemotherapy Induced Adverse Effect (Oral Mucositis) in Head and Neck Cancer.
Date of disclosure of the study information 2011/10/03
Last modified on 2011/10/03

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Basic information
Public title Open Label Study of Hangeshashinto for Prevention of Chemotherapy Induced Adverse Effect (Oral Mucositis) in Head and Neck Cancer.
Acronym Clinical Study of Hangeshashinto for Prevention of Chemoradiotherapy Induced Oral Mucositis in Head and Neck Cancer.
Scientific Title Open Label Study of Hangeshashinto for Prevention of Chemotherapy Induced Adverse Effect (Oral Mucositis) in Head and Neck Cancer.
Scientific Title:Acronym Clinical Study of Hangeshashinto for Prevention of Chemoradiotherapy Induced Oral Mucositis in Head and Neck Cancer.
Region
Japan

Condition
Condition Oropharyngeal or hypopharyngeal squamous cekk carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy (the prevention / curative effect) and safety of TJ-14 for chemoradiotherapy induced oral mucositis in head and neck cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of mucositis (more than grade 1)
Key secondary outcomes Nutrition index
Opioid use
Use of feeding tube
Oral pain

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 Oral administration of Hangeshashinto 7.5g/day t.i.d. after meals.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with histologically or cytologically confirmed squamous cell carcinoma of oropharynx or hypopharynx.
2) Patients who will receive chemotherapy and radiotherapy.
3) Patients who can take TJ-14
4) An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5) Age more than or equal to 20 years at the time of providing informed consent.
6) A life expectancy of more than 12 weeks from.
7) Confirmed by the following data obtained in the 7 days before registration.
hematopoietic function
white blood cell count over 4,000/mm3.
neutrophil count over 1.500/mm3.
platelet count over 100,000/mm3.
renal function
urea nitrogen level below the institutional upper limit of normal.
serum creatinine level below the institutional upper limit of normal or creatinine clearance over 60 ml/min
liver function
aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase levels less than 2 times the institutional upper limit of normal.
8) Patients who will be Hospitalized
9) Written informed consent before initiation of study related procedures.
Key exclusion criteria 1) Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders etc.).
2) Patients who had used traditional Japanese medicines (Kampo) within 2 weeks before registration.
3) Patients who had received antiphlogistic analgetic, opioid, or steroid continuously within 1 month before registration.
4) Patients with planning or during treatment of investigational drug.
5) Chronic constipation.
6) Patients with pregnant, considering pregnancy or lactation.
7) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Fukuda
Organization Hokkaido University Graduate School of Medicine
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hokkaido University Hospital
Division name Department of Otolaryngology
Zip code
Address
TEL
Homepage URL http://www.huhp.hokudai.ac.jp/patient/sec/jibiinkouka/index.html
Email

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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)

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
2011 Year 10 Month 03 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 Preinitiation
Date of protocol fixation
2011 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 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
2011 Year 10 Month 03 Day
Last modified on
2011 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007239

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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