UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of royal jelly for the adverse events of molecular target therapy for renal cancer patients.
Title of the study (Brief title)	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	Yasuyoshi Miyata
Organization	Nagasaki University Hospital
Division name	Urology and Renal transplantation
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	Tomohiro Matsuo
Organization	Nagasaki University Hospital
Division name	Urology and Renal transplantation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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