UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of dexamethasone for pemetrexed-induced rash prevention
Acronym	The efficacy of dexamethasone for PEM-induced rash prevention
Scientific Title	The efficacy of dexamethasone for pemetrexed-induced rash prevention
Scientific Title:Acronym	The efficacy of dexamethasone for PEM-induced rash prevention
Region	Japan

Condition
Condition	non-small cell lung cancer, malignant pleural mesothelioma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of supplementary dexamethasone for pemetrexed-induced rash prevention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of rash within 21 days of pemetrexed administration
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	2 mg/day of dexamethasone is administrated for 5 days, two days later from pemetrexed administration
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-squamous non-small cell lung cancer or malignant pleural mesothelioma, and adequate pemetrexed treatment 2)ECOG-PS 0-2 3)Patients aged 18 or over 4)Folic acid and vitamin B12 was provided at least 1 week before day 1 5)Hospitalized at starting chemotherapy including pemetrexed 6)Meets the following criteria within 14 days before enrollment (a)Hemoglobin level of more than 9.0 g/dL (b)Neutrophil cout of more than 1500/mm3 (c)Platelet cout of more than 100000/mm3 (d)Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range. (e)Aspartate transaminase (AST), alanine transaminase(ALT): less than 3 times the upper limit of normal of the institutional reference range. (f)Creatinine clearance of less than 45mL/min. 7)Written informed consent.
Key exclusion criteria	1)Patients with contraindication of dexamethasone or pemetrexed 2)Using systemic corticosteroid 3)Patients with active infection 4)Using anti-allergenic drug 5)Patients with severe diabetes mellitus that corticosteroids administration is unacceptable 6)Patients with active for hepatitis B antigen and anti-hepatitis C antibody 7)Pregnant / lactating woman, a woman with an intention of pregnancy, a man with a partner who has an intention of pregnancy 8)Combination with cisplatin 9)Patients are judged unqualified for this study by attending physician
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Nishioka Middle name Last name Yasuhiko
Organization	Tokushima University Hospital
Division name	Department of Respiratory medicine and Rheumatology
Zip code	7708503
Address	3-18-15, Kuramoto-cho, Tokushima, Japan
TEL	+81-88-633-7127
Email	yasuhiko@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Sakurada Middle name Last name Takumi
Organization	Tokushima University Hospital
Division name	Department of Pharmacy
Zip code	7708503
Address	2-50-1, Kuramoto-cho, Tokushima, Japan
TEL	+81-88-633-7471
Homepage URL
Email	sakurada@tokushima-u.ac.jp

Sponsor
Institute	Department of Respiratory medicine and Rheumatology, Tokushima University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima, Japan
Tel	+81-88-633-9294
Email	awachiken@tokushima-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	2017 Year 04 Month 01 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	25
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 06 Month 30 Day
Date of IRB	2017 Year 07 Month 24 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2019 Year 04 Month 22 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 01 Month 13 Day
Last modified on	2020 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029383