UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052950 |
|---|---|
| Receipt number | R000060415 |
| Scientific Title | Retrospective Study of Chemotherapy-Induced Peripheral Neuropathy in Gastrointestinal Cancer Patients Receiving Oxaliplatin |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/09/12 13:12:02 |
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Basic information
Public title
Retrospective Study of Chemotherapy-Induced Peripheral Neuropathy in Gastrointestinal Cancer Patients Receiving Oxaliplatin
Acronym
Retrospective Study of Chemotherapy-Induced Peripheral Neuropathy in Gastrointestinal Cancer Patients Receiving Oxaliplatin
Scientific Title
Retrospective Study of Chemotherapy-Induced Peripheral Neuropathy in Gastrointestinal Cancer Patients Receiving Oxaliplatin
Scientific Title:Acronym
Retrospective Study of Chemotherapy-Induced Peripheral Neuropathy in Gastrointestinal Cancer Patients Receiving Oxaliplatin
Region
| Japan |
Condition
Condition
Colon cancer, gastric cancer, esophageal cancer, pancreatic cancer, biliary tract cancer, small intestine cancer, appendix cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to retrospectively examine whether the use of proton pump inhibitors or H2-receptor antagonists during treatment is associated with the development of chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who received oxaliplatin-containing chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of chemotherapy-induced peripheral neuropathy of Grade 2 or higher with or without proton pump inhibitor or H2-receptor antagonist use
Key secondary outcomes
Time to onset of grade 2 or higher chemotherapy-induced peripheral neuropathy with and without use of proton pump inhibitors and H2-receptor antagonists, and percentage of chemotherapy intolerance due to chemotherapy-induced peripheral neuropathy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with gastrointestinal cancer.
2.Chemotherapy including oxaliplatin was started at the Department of Oncology, St. Marianna University Hospital from January 1, 2020 to September 30, 2023.
Key exclusion criteria
Cases in which the principal investigator determines that participation in this study is inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Uchida |
Organization
St. Marianna Medical University
Division name
Division of clinical oncology
Zip code
2168511
Address
2-16-1 Sugo, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
yoshiyasu.uchida@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Uchida |
Organization
St. Marianna Medical University
Division name
Division of clinical oncology
Zip code
2168511
Address
2-16-1 Sugo, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
Homepage URL
yoshiyasu.uchida@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna Medical University
Institute
Department
Personal name
Yoshiyasu Uchida
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
St. Marianna Medical University
Address
2-16-1 Sugo, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
Tel
044-977-8111
yoshiyasu.uchida@marianna-u.ac.jp
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 | 12 | Month | 01 | 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
110
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 12 | Day |
Other
Other related information
The clinical information to be collected is as follows
(1) Clinical information at the start of treatment (age, gender, BMI, ECOG PS, carcinoma, clinical stage, number of metastatic organs, regimen, treatment line, Hb, Alb, Mg, diabetes, history of statin use, alcohol consumption, smoking history, peripheral neuropathy grade, history of taxane anticancer drug use)
(2) Dose and duration of oxaliplatin administration
(3) Clinical information during oxaliplatin administration (worst grade of peripheral neuropathy, intolerance due to peripheral neuropathy, use of NSAIDs, use of analgesics, onset of grade 2 or higher peripheral neuropathy and total dose of L-OHP at that time, use of PPI/H2B and duration of administration)
(4) New collection items may be added as needed.
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060415
