UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Title of the study (Brief title)	A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Region	Japan

Condition
Condition	Peripheral neuropathy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study whether consumption of cystine and theanine ameliorate peripheral neuropathy caused by oxaliplatin in colon cancer patients receiving mFOLFOX6 therapy which is a combination of oxaliplatin, fluorouracil and folinic acid by comparing with no sonsumpting control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Suppressive effect of cystine and theanine on occurrence of peripheral neuropathy during receiving mFOLFOX6 therapy (Max. 6 months)
Key secondary outcomes	State of occurrence of other adverse events of grade 2 or more. Total amount of administered oxaliplatin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing 700mg of cystine and 280mg of theanine once a day during receiving mFOLFOX6 therapy (Max. 6 months)
Interventions/Control_2	No ingestion of supplement instead of cystine and theanine during receiving mFOLFOX6 therapy.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.From 20 to 80 years old. 2.Performance status 0-1. 3.Able to oral ingestion. 4.Received a written informed consent by patient's self-determination.
Key exclusion criteria	1.Active infection. 2.Poorly controlled hypertension. 3.Poorly controlled diabetes. 4.Clinically important cardiac disease. 5.Severe pulmonary disease (e.g. interstitial pneumonia , fibrosis, severe emphysema). 6.HIstory of clinically important psychopathic disorder or central nervous system damage. 7.Continuous systemic administration (iv or po) of steroid. 8.Pregnancy, breast-feeding, possible pregnancy and willing to be pregnant. 9.Participation for other studies. 10.Impossible of oral ingestion. 11.Judged ineligible by the principal investigator or sub-investigators.
Target sample size	40

Research contact person
Name of lead principal investigator	Takashi Tsuchiya
Organization	Sendai City Medical Center, Sendai Open Hospital
Division name	Director of the hospital, digestive surgery
Address	5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL	022-252-1111
Email	tsuchiya@openhp.or.jp

Public contact
Name of contact person	Takashi Tsuchiya
Organization	Sendai City Medical Center, Sendai Open Hospital
Division name	Director of the hospital, digestive surgery
Address	5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL	022-252-1111
Homepage URL
Email	tsuchiya@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center, Sendai Open Hospital
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shirakawa Kosei General Hospital
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	仙台市医療センター仙台オープン病院（宮城県） 白河厚生病院（福島県）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 21 Day
Anticipated trial start date	2015 Year 01 Month 28 Day
Last follow-up date	2018 Year 08 Month 15 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2018 Year 10 Month 31 Day

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

Management information
Registered date	2016 Year 01 Month 06 Day
Last modified on	2018 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023636