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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000028378 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Gastrointestinal disease | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Group A
Duration 60 days Dose Cystine&Theanine 1.5g/day Then discontinue 30 days and observe |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Hamamatsu Medical Center |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |