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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020456
Receipt No. R000023636
Scientific Title A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Date of disclosure of the study information 2016/01/07
Last modified on 2018/08/08

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Basic information
Public title A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Acronym A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Scientific Title A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Tsuchiya
Organization Sendai City Medical Center, Sendai Open Hospital
Division name Director of the hospital, digestive surgery
Zip code
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
1st name
Middle name
Last name Takashi Tsuchiya
Organization Sendai City Medical Center, Sendai Open Hospital
Division name Director of the hospital, digestive surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2014 Year 11 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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