UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Oral Administration of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine based Adjuvant Chemotherapy after Surgery: Randomized, Double-blind, Placebo controlled, Phase-II Study
Acronym	Efficacy of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine after Surgery: Placebo controlled, Phase-II Study
Scientific Title	Efficacy of Oral Administration of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine based Adjuvant Chemotherapy after Surgery: Randomized, Double-blind, Placebo controlled, Phase-II Study
Scientific Title:Acronym	Efficacy of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine after Surgery: Placebo controlled, Phase-II Study
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of Cystine and Theanine in colorectal cancer patients undergoing capecitabine based adjuvant chemotherapy after surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence rate of Grade 1 or more diarrhea (CTCAE v4.0)
Key secondary outcomes	1) Score of EORTC QLQ-C30 and QLQ-CR29 2) Incidence rate of Grade 1 or more hand-foot syndrome (Classification of Blum) 3) Incidence rate of Grade 2 or more diarrhea (CTCAE v4.0) 4) Incidence rate of Grade 1 or more and Grade 2 or more adverse events (white blood cell count, neutrophill count, hemoglobin, platelet count, total bilirubin, ALP, AST, ALT, gamma-GTP, creatinine, and adverse events other than diarrhea) 5) Adherence to medication (Cystine and Theanine or placebo) 6) Completion rate of four cycles of capecitabine without interruption or reduction 7) Duration of capecitabine therapy (four cycles) 8) Total dose of capecitabine

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	One pack (Cystine 700 mg/day and Theanine 280 mg/day) to be taken after breakfast, daily oral administration
Interventions/Control_2	One pack (placebo) to be taken after breakfast, daily oral administration
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. Written informed consent 2. Age: 20-80 years 3. Histologically confirmed colorectal cancer 4. Capecitabine therapy will be taken after resection of colorectal cancer 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 6. Vital organ functions (listed below) are preserved within 14 days prior to registration 1) WBC >= 3000/mm3 2) Platlet >= 75000/mm3 3) Hemoglobin >= 9.0 g/dL 4) Total bilirubin <= 2.0 mg/dL 5) AST <= 100 U/L 6) ALT <= 100 U/L 7) Serum creatinine <= 1.5 mg/dL
Key exclusion criteria	1. Past history of chemotherapy 2. Past history of radiotherapy 3. Administration of amino acid supplement (including protein supplement) 4. Prior administration of Cystine and Theanine 5. Administration of supplements derived from herbs (St. John's wort, etc.), not including multivitamins 6. Pregnant or lactating patient 7. Immunodeficiency 8. Phenylketonuria 9. Registered in other clinical trials 10. Cognitive disorder (dementia, deliria, and decreased level of consciousness, etc.) 11. Psychiatric/neurological disorder 12. Aphasia, aphonia, and dysarthria 13. Oral intake difficulty 14. Malabsorption syndrome 15. Past history of gastrectomy 16. Active gastrointestinal bleeding 17. Inappropriate for the study at the physician's assessment
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takashi Tsuchiya
Organization	Sendai City Medical Center Sendai Open Hospital
Division name	Department of Gastroenterological Surgery
Zip code
Address	5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL	022-252-1111
Email	tsuchiya@openhp.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Reo Hamaguchi
Organization	Research Hospital of the Institute of Medical Science, The University of Tokyo
Division name	Department of Palliative Medicine
Zip code
Address	4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL	03-3443-8111
Homepage URL
Email	reo-h@nifty.com

Sponsor
Institute	Non-Profit Organization JORTC
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 11 Month 10 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	2016 Year 09 Month 29 Day
Date of IRB	2016 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 11 Month 14 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 10 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028500