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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036701
Receipt No. 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 2019/05/10

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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
Email 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
Email katsuno@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2019 Year 12 Month 28 Day
Date of closure to data entry
2019 Year 12 Month 28 Day
Date trial data considered complete
2020 Year 01 Month 31 Day
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information Not applicable

Management information
Registered date
2019 Year 05 Month 10 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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