UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of acetaminophen in the treatment of patients with head and neck cancer
Acronym	Acetaminophen in the treatment of patients with head and neck cancer
Scientific Title	Efficacy and safety of acetaminophen in the treatment of patients with head and neck cancer
Scientific Title:Acronym	Acetaminophen in the treatment of patients with 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	To compare the efficacy and safety of acetaminophen and etodolac in pain management of Japanese patients with head and neck cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain scores while eating
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Acetaminophen
Interventions/Control_2	Etodolac
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	Japanese patients who 1.were diagnosed as having head and neck cancer. 2.are undergoing chemoratiotherapy. 3.are complaining of pain (NRS1-6) caused by mucositis. 4.have not taken analgesic agents yet. 5.are thought to be relieved by non-opioid analgesics. 6.can take analgesic agents orally. 7.can give written informed consent.
Key exclusion criteria	1.Patients with peptic ulcer 2.Patients with severe blood disorder 3.Patients with severe liver dysfunction 4.Patients with severe renal dysfunction 5.Patients with severe cardiac dysfunction 6.Patients with known hypersensitivity to acetaminophen or etodolac 7.Female patients who are pregnant, lactating or possibly pregnant 8.Patients who are judged inappropriate for the clinical trial by attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ken-ichi Kaneko
Organization	Nagasaki University Hospital
Division name	Department of Otolaryngology
Zip code
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-801-7711
Email	kkaneko@ba2.so-net.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Ken-ichi Kaneko
Organization	Nagasaki University Hospital
Division name	Department of Otolaryngology
Zip code
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-801-7711
Homepage URL
Email	kkaneko@ba2.so-net.ne.jp

Sponsor
Institute	Department of Otolaryngology, Nagasaki 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	2012 Year 11 Month 08 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 09 Month 25 Day
Date of IRB	2012 Year 05 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2014 Year 11 Month 30 Day
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 08 Day
Last modified on	2019 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010522