UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity
Title of the study (Brief title)	The preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This is the phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity as to adjuvant chemotherapy for patients with stage II and III colorectal cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decision of DLT, MTD, RD of Kampo medicine (TJ-3023, TJ-18)
Key secondary outcomes	Decision of RDI of oxaliplatin, Examination for oxaliplatin-induced peripheral neurotoxicity (neurosensory test, QOL)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	During XELOX regimen, Kampo medicine is administered as follows: Level 1(TJ-18 7.5g, TJ-3023 0g), Level 2(TJ-18 7.5g, TJ-3023 1.5g), Level 3(TJ-18 7.5g, TJ-3023 3.0g)
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.histopathological colorectal cancer 2.stage II or III 3.adjuvant chemotherapy using oxaliplatin 4. more than 20 yeras old 5. ECOG Performance Status 0-1 6.no organ failure 7.no chemotherapy 8.informed consent
Key exclusion criteria	1.having resistance for using Kampo 2. chemotherapy using oxaliplatin has been performed 3.having double cancer 4.having serious sensory disturbance 5.having serious drug hypersensitivity 6. having serious infection 7. having serious psycho-neurologic disease 8.having serious complication as follows: uncontrorable diabetes mellitus, uncontrorable hypertension, interstitial pneumonia or pulmonary fibrosis, ileus, and serious heart disease 9. inappropriate judgment for study by clinical investigator
Target sample size	18

Research contact person
Name of lead principal investigator	Tsukasa Hotta
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	hotta@wakayama-med.ac.jp

Public contact
Name of contact person	Tsukasa Hotta
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	hotta@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2014 Year 12 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 07 Day
Anticipated trial start date	2014 Year 12 Month 29 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

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

Management information
Registered date	2014 Year 12 Month 29 Day
Last modified on	2019 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018685