UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024233
Receipt number 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 14:32:21

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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 or person

Institute

International university health and welfare university Mita hospital

Institute

Department

Personal name



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

Value
https://center6.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