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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021740
Receipt No. R000025077
Scientific Title Randomized control trial of effect of apitherapy to prevent salivary gland disorder during I-131 ablation in patients with differentiated thyroid cancer.
Date of disclosure of the study information 2016/04/07
Last modified on 2016/05/09

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Basic information
Public title Randomized control trial of effect of apitherapy to prevent salivary gland disorder during I-131 ablation in patients with differentiated thyroid cancer.
Acronym Effect of apitherapy to prevent salivary gland disorder during I-131 ablation.
Scientific Title Randomized control trial of effect of apitherapy to prevent salivary gland disorder during I-131 ablation in patients with differentiated thyroid cancer.
Scientific Title:Acronym Effect of apitherapy to prevent salivary gland disorder during I-131 ablation.
Region
Japan

Condition
Condition thyroid cancer
Classification by specialty
Radiology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effect of apitherapy to prevent salivary gland disorder after I-131 ablation in patients with differentiated thyroid cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes salivary gland disorder
Key secondary outcomes

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 Prevention
Type of intervention
Food
Interventions/Control_1 Apitherapy using honey
Interventions/Control_2 control
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)a patient who underwent total thyroidectomy for thyroid cancer
2)submitted written consent as a participant
Key exclusion criteria 1)a patient with cognitive impairment
2)pregnant female and feeding female
3) a patient with diabetes mellitus
4)when medical staff determine that treatment can not be properly carried out
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Nakayama
Organization Asahikawa Medical University
Division name Department of Radiology
Zip code
Address 2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL 0166-68-2572
Email m-naka@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michihiro Nakayama
Organization Asahikawa Medical University
Division name Department of Radiology
Zip code
Address 2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL 0166-68-2572
Homepage URL
Email m-naka@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization JSPS Grant-in-Aid for Young Scientists (B) 16K20745
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 04 Month 07 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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 06 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 04 Month 01 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025077

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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