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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020152
Receipt No. R000023278
Scientific Title The effects of royal jelly for the adverse events of molecular target therapy for renal cancer patients.
Date of disclosure of the study information 2015/12/15
Last modified on 2018/11/07

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Basic information
Public title The effects of royal jelly for the adverse events of molecular target therapy for renal cancer patients.
Acronym The effects of royal jelly for the adverse events of molecular target therapy for renal cancer patients.
Scientific Title The effects of royal jelly for the adverse events of molecular target therapy for renal cancer patients.
Scientific Title:Acronym The effects of royal jelly for the adverse events of molecular target therapy for renal cancer patients.
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Some molecular target therapies are effctive for the renal cell carcinoma. However, some patients are suffering from adverse events,stomatitis, hypertension, and hand-foot syndrome. The mainly aim for this study is to examine the preventive effects of royal jelly for the adverse events of the molecular target therapies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of royal jelly for the skin problem of the molecular target therapy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 We examine this research using double-blind method. We divide the patients into two groups, royal jelly group and placebo-control group.The group of royal jelly patients take 2400mg /day royal jelly for 90 days.
Interventions/Control_2 The patients of placebo group take encapsulated drugs 3 times a day for 90 days
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 1. renal cell carcinoma patient
2. performance status 0-1
3. WBC 3000/mm3 <=
Neutro:1500/mm3 <=
PLT:100,000/mm3 <=
Hb:8g/dl <=
AST and ALT:Upper limit 3 times or less
T.Bil:1.5mg/dl =>
Crea:2.0mg/dl =>
FB:125mg/dl =>
4. Those who can start this research within two weeks after resistration.
5. those who are 20 years and older
6. those who allow the participation for this study
Key exclusion criteria 1. those who have possibility of the cancer death within six months
2.those who have allergy for honey
3. those who have some allergy for foods and drugs
4. those who have another cancer
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Miyata
Organization Nagasaki University Hospital
Division name Urology and Renal transplantation
Zip code
Address 1-7-1,Samkamoto, Nagasaki, Japan
TEL 095-819-7340
Email int.doc.miya@m3.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Matsuo
Organization Nagasaki University Hospital
Division name Urology and Renal transplantation
Zip code
Address 1-7-1,Samkamoto, Nagasaki, Japan
TEL 095-819-7340
Homepage URL
Email tomo1228@nagasaki-u.ac.jp

Sponsor
Institute Department of Urology and Renal transplantation, Nagasaki University Hospital
Institute
Department

Funding Source
Organization Yamada Research Grant
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2015 Year 12 Month 15 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
2015 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 10 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023278

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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