UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021740 |
|---|---|
| Receipt number | 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 | 2020/08/14 10:03:56 |
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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 | Michihiro |
| Middle name | |
| Last name | Nakayama |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
0788510
Address
2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL
0166-68-2572
m-naka@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Nakayama |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
0788510
Address
2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL
0166-68-2572
Homepage URL
m-naka@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
Asahikawa Medical University
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 0
Tel
0166-68-2572
m-naka@asahikawa-med.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
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025077
