Unique ID issued by UMIN | UMIN000024233 |
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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 |
A study of early phase opioid induction in radiation therapy for head and neck cancer
A study of early phase opioid induction in radiation therapy for head and neck cancer
A study of early phase opioid induction in radiation therapy for head and neck cancer
A study of early phase opioid induction in radiation therapy for head and neck cancer
Japan |
Head and neck cancer
Oto-rhino-laryngology |
Malignancy
NO
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.
Safety,Efficacy
rate of pain (NRS score),ingestion interruption
amount of total opioid, amount of ingestion, weight loss, rate of adverse event, clinical response rate, days of hospitalization
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Treatment
Medicine |
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)
* 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)
20 | years-old | <= |
Not applicable |
Male and Female
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
Do not required the criteria shown above
40
1st name | |
Middle name | |
Last name | Chihiro Kanno |
International university health and welfare university Mita hospital
Head and neck oncology center
1-4-3 Mita Minato ward Tokyo
03-3451-8121
chihiri@iuhw.ac.jp
1st name | |
Middle name | |
Last name | Chihiro Kanno |
International university health and welfare university Mita hospital
Head and neck oncology center
1-4-3 Mita Minato ward Tokyo
03-3451-8121
chihiri@iuhw.ac.jp
International university health and welfare university Mita hospital
International university health and welfare university Mita hospital
Self funding
NO
国際医療福祉大学三田病院(東京都)
2016 | Year | 09 | Month | 30 | Day |
Unpublished
Open public recruiting
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 09 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027900
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