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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024233
Receipt No. R000027900
Scientific Title A study of early phase opioid induction in radiation therapy for head and neck cancer
Date of disclosure of the study information 2016/09/30
Last modified on 2016/09/30

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Basic information
Public title A study of early phase opioid induction in radiation therapy for head and neck cancer
Acronym A study of early phase opioid induction in radiation therapy for head and neck cancer
Scientific Title A study of early phase opioid induction in radiation therapy for head and neck cancer
Scientific Title:Acronym A study of early phase opioid induction in radiation therapy 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 In unresectable or local advanced head and neck cancer, chemoradiation therapy is the standard therapy. Thus, hard sideeffect and long term therapy causes interruption or omission of scheduled menu. It is due to insufficient pain control, then consequently insufficient ingestion and general weakness occur. Sufficient and effective new pain control method is required.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of pain (NRS score),ingestion interruption
Key secondary outcomes amount of total opioid, amount of ingestion, weight loss, rate of adverse event, clinical response rate, days of hospitalization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 arm comparing trial.
* Early phase opioid group: When amount of ingestion is gained, start administrating Acetaminophen 3200mg/day (4times before every meal and sleep) and Oxycodone 10mg/day (per 12hour)
Interventions/Control_2 * Control group: When amount of ingestion is gained, start administrating Acetaminophen 3200mg/day (4times before every meal and sleep)and Pracebo drug (Praceplus 2Tablets/day per 12h)
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) Head and neck cancer patient
2) 3 methods (Radiation alone, Chemoradiation with CDDP, Chemoradiation with cetuximab)
3) No every pain killer use when therapy start
4) Possible to ingestion
5) Labo data shown below are requiered
a) AST <100IU/L
b) ALT <100IU/L
c) Total bilirubin < 2.0 mg/dl
6) No psychorogical disease such effect on daily living and personal relation
7) Patients admission for participate this trial is obtained
Key exclusion criteria Do not required the criteria shown above
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chihiro Kanno
Organization International university health and welfare university Mita hospital
Division name Head and neck oncology center
Zip code
Address 1-4-3 Mita Minato ward Tokyo
TEL 03-3451-8121
Email chihiri@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chihiro Kanno
Organization International university health and welfare university Mita hospital
Division name Head and neck oncology center
Zip code
Address 1-4-3 Mita Minato ward Tokyo
TEL 03-3451-8121
Homepage URL
Email chihiri@iuhw.ac.jp

Sponsor
Institute International university health and welfare university Mita hospital
Institute
Department

Funding Source
Organization International university health and welfare university Mita hospital
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 国際医療福祉大学三田病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 30 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
2016 Year 09 Month 30 Day
Last modified on
2016 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027900

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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