UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028378 |
|---|---|
| Receipt number | R000032486 |
| Scientific Title | Reduction of the Side Effects during Chemotherapy by Amino Acids |
| Date of disclosure of the study information | 2017/07/26 |
| Last modified on | 2017/07/26 09:48:18 |
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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
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
yikemats@hmedc.or.jp
Sponsor or person
Institute
Hamamatsu Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032486
