UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020456 |
|---|---|
| Receipt number | 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 17:44:24 |
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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
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
tsuchiya@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center, Sendai Open Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023636
