UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy
Acronym	Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy
Scientific Title	Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy
Scientific Title:Acronym	Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy
Region	Japan

Condition
Condition	breast cancer, gastric cancer, colorectal cancer, esophageal cancer, gynecological cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the feasibility of cooral system
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Feasibility for Cooral system during the first chemotherapy cycle.
Key secondary outcomes	1.Grade of oral mucositis according to NCI-CTCAE. 2.Patient reported outcome of impression of use. 3.Patients' diary of oral mucositis measured. 4.Rating of oral pain measured with a Numerical Rating Scale. 5.Feasibility for Cooral system during the subsequently cycles.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Before the start of treatment the patient receives clear oral and written instructions on the use of Cooral by the nurse responsible for the patient. The patient him/herself is able to administer the intraoral component until it feels comfortable. Then the responsible staff check to ensure that it has good contact with the oral mucous membrane. Cooling begins 30 minutes before the start of chemotherapy. Cooling continues until 30 minutes after the termination of the cytostatic infusion. During treatment the patient may if necessary take out the component and replace it again, for a maximum of 10 minutes. Food should thus be taken before or after chemotherapy.
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 for planning to administer alkylating agents, platinum, anthracycline, antimetabolite, or taxanes. 2. Out patients. 3. To write diary every day. 4. To obtain written informed consent.
Key exclusion criteria	1. Patients who have infectious disease 2. Patients who have any oral disease and not able to wear the mouth device. ( Patients can include that they are able to wear the device although they have any oral disease. ) 3. Patients of oral cancer. 4. Patients who have received prior radiotherapy for oral. 5. Patients who have received bolus administration of chemotherapy agents.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Akiko Konomatsu
Organization	NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Division name	Pharmacy
Zip code
Address	1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA
TEL	044-733-5181
Email	akk-koo@nms.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Akiko Konomatsu
Organization	NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Division name	Pharmacy
Zip code
Address	1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA
TEL	044-733-5181
Homepage URL
Email	akk-koo@nms.ac.jp

Sponsor
Institute	NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Institute
Department

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
Address
Tel
Email

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	2018 Year 10 Month 15 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	Completed
Date of protocol fixation	2017 Year 12 Month 14 Day
Date of IRB	2017 Year 12 Month 22 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 13 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039316