UMIN-CTR Clinical Trial

Basic information
Public title	Reduction of the Side Effects during Chemotherapy by Amino Acids
Acronym	Reduction of the Side Effects during Chemotherapy by Amino Acids
Scientific Title	Reduction of the Side Effects during Chemotherapy by Amino Acids
Scientific Title:Acronym	Reduction of the Side Effects during Chemotherapy by Amino Acids
Region	Japan

Condition
Condition	Gastrointestinal disease
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Confirmation of supplement administration of amino acids cystine and theanine on both adverse events and nutritional status during adjuvant chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Verification of improve rates after one month of supplementation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Group A Duration 60 days Dose Cystine&Theanine 1.5g/day Then discontinue 30 days and observe
Interventions/Control_2	Group B Duration 30 days Dose Cystine&Theanine 1.5g/day Followed by interuptiuon 30 days and resume 30 days then observe
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Out patients under adjuvant chemotherapy after GI surgery with more than 3 gastrointestinal adverse events (CTCAE v4.0) who will receive treatment more than 4 months.
Key exclusion criteria	1. History or present usage of Cytine and Theanine supplementation. 2. Patinets with severe metabolic disease (ex. uncontrolled diabetes, refractory cachexia or respiratory failure). 3. Patients with swallowing disturbance. 4. Physisians decision.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshito Ikematsu
Organization	Hamamatsu Medical Center
Division name	Gastroenterological Surgery
Zip code
Address	Tomitsuka 328, Hamamatsu City
TEL	053-453-7111
Email	yikemats@hmedc.or.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshito Ikematsu
Organization	Hamamatsu Medical Center
Division name	Gastroenterological Surgery
Zip code
Address	Tomitsuka 328, Hamamatsu City
TEL	053-453-7111
Homepage URL
Email	yikemats@hmedc.or.jp

Sponsor
Institute	Hamamatsu Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 26 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	Preinitiation
Date of protocol fixation	2017 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2017 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032486

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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