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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024784
Receipt No. R000028500
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
Date of disclosure of the study information 2016/11/10
Last modified on 2019/04/03

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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
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
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

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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