UMIN-CTR Clinical Trial

Basic information
Public title	Crinical evaluation of zinc acetate for prevention of mucositis associated with radiotherapy in patients with head and neck cancer
Acronym	Crinical evaluation of zinc acetate for prevention of mucositis associated with radiotherapy in patients with head and neck cancer
Scientific Title	Crinical evaluation of zinc acetate for prevention of mucositis associated with radiotherapy in patients with head and neck cancer
Scientific Title:Acronym	Crinical evaluation of zinc acetate for prevention of mucositis associated with radiotherapy in 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	The aim of this study was to evaluate the effect of zinc acetate for prevention of mucositis associated with radiotherapy in patients with head and neck cancer, and compare the grade of mucositis with histirical control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The worst grade of pharyngeal mucositis
Key secondary outcomes	Pharyngeal mucositis during radiation therapy of every week

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	oral medication of zinc acetate.medication starts from the beginning of radiation therapy.medication dose is 100mg/day,range 25-150mg associated with side effect of zinc acetate.medication period is 6-7weeks during radiation therapy.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) WHO PS 0-2 2) Advanced head and neck cancer,oral cavity is irradiated 3) Treated by radiotherapy and concomitant chemotherapy with cisplatin 4) Onset of mucositis is certain 5) Not diagnosted as dementia 6) Satisfy the diagnostic criteria of zinc deficiency(clinical and subclinical) advocated by japanese society of clinical nutrition
Key exclusion criteria	1) Patients that subjective examination is difficult(i.e. patient with dementia, under 19 years old) 2) Patients under life-threatening situation. 3) Patients who is assesed by researcher as ungrammatical for this study
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Takehito Middle name Last name Kishino
Organization	Kagawa university hospital
Division name	Otolaryngology-Head and Neck Surgery
Zip code	7610793
Address	1750-1,Ikenobe,Miki-cho,Kita-gun,Kagawa
TEL	087-891-2214
Email	kissie@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Takehito Middle name Last name Kishino
Organization	Kagawa university hospital
Division name	Otolaryngology-Head and Neck Surgery
Zip code	761-0793
Address	1750-1,Ikenobe,Miki-cho,Kita-gun,Kagawa
TEL	087-891-2214
Homepage URL
Email	kissie@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa university hospital Otolaryngology-Head and Neck Surgery
Institute
Department

Funding Source
Organization	Self funding
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	Kagawa university Institutional Review Board
Address	1750-1,Ikenobe,Miki-cho,Kita-gun,Kagawa
Tel	0878985111
Email	kissie@med.kagawa-u.ac.jp

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	香川大学病院(香川県)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 29 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	2018 Year 01 Month 22 Day
Date of IRB	2018 Year 01 Month 12 Day
Anticipated trial start date	2018 Year 01 Month 29 Day
Last follow-up date	2020 Year 09 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	2018 Year 01 Month 24 Day
Last modified on	2021 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035132