UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034478 |
|---|---|
| Receipt number | R000039316 |
| Scientific Title | Feasibility study of Cooral system for oral mucositis in patients receiving chemotherapy |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2019/04/24 13:23:38 |
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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
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
akk-koo@nms.ac.jp
Public contact
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
akk-koo@nms.ac.jp
Sponsor or person
Institute
NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039316
