UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Acronym	Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Scientific Title	Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Scientific Title:Acronym	Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Region	Japan

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

Objectives
Narrative objectives1	To investigate the safety and efficacy of bis-glyceryl ascorbate-containing cream for hand-foot skin reaction in renal cell carcinoma patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phase I: Cutaneous abnormality including erythem, edema, papula, and vesicle Phase II: Incidence of HFSR of grade 1 of higher within 6 weeks after initiation of sunitinib treatment
Key secondary outcomes

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	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Patients are applied Amitose-bis-glyceryl ascorbate to palmar and planter region three times or higher a day with concomitant administration of 10% urea or heparinoid-containing cream.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who give informed consent and who are 20 years of age at least 2) Patients who were diagnosed renal cell carcinoma 3) Patients who recieve sunitinib treatment including previously treatment of targeted therapy and neoadjuvant therapy 4) ECOG PS: 0-2 5) Patients who are expected to survive at least 12 weeks 6) Patients who observe the protocol compliance
Key exclusion criteria	1) Patients in whom the underlying disease is a dermatological disease at palmar and planter region at initiation of sunitinib treatment 2) Patients who are applied external medicine not involving 10% urea and heparinoid-containing cream to palmar and planter region at initiation of sunitinib treatment 3) Patients who are not able to apply 10% urea or heparinoid-containing cream to palmar and planter region 4) Patients with HFSR of grade 1 or higher at initiation of sunitinib treatment 5) Patients with infections which needs systemic treatment 6) Patients with severe hepatic disorder 7) Patients with severe renal disorder 8) Patients who are lack of felicity
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Chikako Middle name Last name Nishigori
Organization	Kobe University Hospital
Division name	Dermatology
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6641
Email	chikako@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kauhiro Middle name Last name Yamamoto
Organization	Kobe University Hospital
Division name	Pharmacy
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6659
Homepage URL
Email	yamakz@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Momotani Juntenkan LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical and Translational Research Center, Kobe University Hospital
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel	078-382-6669
Email	chiken@med.kobe-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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 27 Day

Related information
URL releasing protocol	https://www.researchprotocols.org/2019/8/e14636/
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyab067/6548146
Number of participants that the trial has enrolled	24
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	2017 Year 08 Month 22 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 08 Month 22 Day
Last follow-up date	2022 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	2017 Year 05 Month 01 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031174