UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024784 |
|---|---|
| Receipt number | 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 09:09:03 |
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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
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
reo-h@nifty.com
Sponsor or person
Institute
Non-Profit Organization JORTC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028500
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