UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052622 |
|---|---|
| Receipt number | R000060047 |
| Scientific Title | Cystine and Theanine for Chemoradiotherapy induced esophagitis in non-small cell lung cancer: a prospective single-arm study |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2024/01/08 16:47:17 |
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Basic information
Public title
Cystine and Theanine for Chemoradiotherapy induced esophagitis in non-small cell lung cancer: a prospective single-arm study
Acronym
Cystine and Theanine for Chemoradiotherapy induced esophagitis in non-small cell lung cancer: a prospective single-arm study
Scientific Title
Cystine and Theanine for Chemoradiotherapy induced esophagitis in non-small cell lung cancer: a prospective single-arm study
Scientific Title:Acronym
Cystine and Theanine for Chemoradiotherapy induced esophagitis in non-small cell lung cancer: a prospective single-arm study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our purposes were to investigate the efficacy and safety of cystine and theanine for esophagitis in non-small cell lung cancer patients undergoing chemoradiotherapy and to explore the feasibility of conducting this study on a large scale.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence rate of esophagitis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Locally advanced NSCLC patients who had scheduled to receive weekly paclitaxel or nab-paclitaxel/carboplatin plus RT (60Gy/30Fr) for 6 weeks and scheduled to administer 700 mg cystine and 280 mg theanine orally once daily from the start of CRT until completion were included in the study.
Key exclusion criteria
Patients were excluded who had a psychiatric disorder that may affect data sampling, a cognitive impairment, malabsorption syndrome, and an incapable to oral ingestion.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Kariya |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Department of Pharmacy
Zip code
650-0046
Address
8-5-1, Nakamati Minatojima, Chuo-Ku, Kobe, Hyogo 650-0046, Japan
TEL
0783044100
misatokariya1204@gmail.com
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Kariya |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Department of Pharmacy
Zip code
651-0061
Address
8-5-1, Nakamati Minatojima, Chuo-Ku, Kobe, Hyogo 650-0046, Japan
TEL
0783044100
Homepage URL
misatokariya1204@gmail.com
Sponsor or person
Institute
Kobe Minimally Invasive Cancer Center
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Minimally Invasive Cancer Center
Address
8-5-1, Nakamati Minatojima, Chuo-Ku, Kobe, Hyogo 650-0046, Japan
Tel
0783044100
misatokariya1204@gmail.com
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
| 2023 | Year | 10 | 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
26
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
| 2021 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Incidence of esophagitis during chemoradiotherapy, severity of esophagitis, adverse events, trends in QOL surveys, and dosage rate of cystine and theanine.
Management information
Registered date
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060047
