UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036701 |
|---|---|
| Receipt number | R000038062 |
| Scientific Title | Establishment of the cold sensation detection threshold examination using menthol solution before and after oxaliplatin infusion in patients with colorectal cancer. |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2022/11/11 14:16:02 |
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Basic information
Public title
Establishment of the cold sensation detection threshold examination using menthol solution before and after oxaliplatin infusion in patients with colorectal cancer.
Acronym
Establishment of the menthol solution examination before and after oxaliplatin infusion in patients with colorectal cancer.
Scientific Title
Establishment of the cold sensation detection threshold examination using menthol solution before and after oxaliplatin infusion in patients with colorectal cancer.
Scientific Title:Acronym
Establishment of the menthol solution examination before and after oxaliplatin infusion in patients with colorectal cancer.
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to establish the feasibility of undertaking cold sensation detection threshold test using l-menthol applying to the tongue in a clinical setting to facilitate the identification of early neurotoxicity by oxaliplatin administration in patients with colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to establish the feasibility of undertaking cold sensation detection threshold test using l-menthol applying to the tongue in a clinical setting to facilitate the identification of early neurotoxicity by oxaliplatin administration in patients with colorectal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cold sensation detection threshold using l-menthol before and after oxaliplatin administration
Key secondary outcomes
1) The grading of sensory nerve impairment
･ The National Cancer Institute Common Terminology Criteria for Adverse Events CTCAE version4.0
･ DEB-NTC
･ Asahikawa university criteria
2) Vibratory sensation test with tuning fork
3) Pain Numerical Rating Scale
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Unresectable advanced and recurrent colorectal cancer patients who never undertake oxaliplatin.
2) The pStage II or III patients who will be administered oxaliplatin as adjuvant chemotherapy.
3) The subjects do not consume any spicy food 1 day prior to testing.
4)The subjects are asked to refrain from eating, drinking, chewing gum, brushing their teeth, and using mouth wash for 2hours before testing.
Key exclusion criteria
1) Multicentric cancer patient
2) A patient with peripheral nerve disorder.
3)A patient who has a history of severe drug allergy.
4) A woman who is or may be pregnant.
5) A patient with mental disorder
6) An ineligible patient for a clinical trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Katsuno |
Organization
Fujita Health University
Division name
Department of Surgery
Zip code
4701192
Address
Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2188
katsuno@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Katsuno |
Organization
Fujita Health University
Division name
Department of Surgery
Zip code
4701192
Address
Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2188
Homepage URL
katsuno@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Center for research promotion and support, Fujita Health University
Address
Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, Japan
Tel
0562-93-2139
kensien@fujita-hu.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
| 2019 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.20407/fmj.2021-011
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.20407/fmj.2021-011
Number of participants that the trial has enrolled
41
Results
The mean CDT before the first oxaliplatin dose was measured in colorectal cancer patients. Two patients were excluded because their data were incomplete, and one patient was excluded because they withdrew their consent. The mean CDT before the first dose was 0.34%(n=38), and the mean CDT after the first dose was 0.32% (n=38). Although the CDT appeared to decrease from before the first dose to after the first dose, this difference was not significant.
Results date posted
| 2022 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unresectable advanced and recurrent colorectal cancer
cases without chemotherapy
Participant flow
On the day before testing, all subjects needed to refrain
from ingesting foods containing spices and stimulants
Within 2 hours of testing, all subjects needed to refrain
from eating, chewing gum, or using toothpaste
Adverse events
There was any adverse events observed.
Outcome measures
1. Comparison of the CDT before and after the first administration of oxaliplatin. CDT comparisons by age.
2. Changes in the CDT in patients receiving five doses
of oxaliplatin. CDT comparisons by age.
3. Using the DEB-NTC scale, a questionnaire about
peripheral neuropathy was conducted before the oxaliplatin administration, and its association with the CDT was
then analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038062
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