UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002411 |
|---|---|
| Receipt number | R000002955 |
| Scientific Title | Oral Cooling (Cryotherapy),an Effective Treatment for prevention of Chemotherapy-Related Stomatitis , a randomized controlled trial |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2023/09/11 17:16:04 |
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Basic information
Public title
Oral Cooling (Cryotherapy),an Effective Treatment for prevention of Chemotherapy-Related Stomatitis , a randomized controlled trial
Acronym
Oral Cooling (Cryotherapy),an Effective Treatment for prevention of Chemotherapy-Related Stomatitis , a randomized controlled trial
Scientific Title
Oral Cooling (Cryotherapy),an Effective Treatment for prevention of Chemotherapy-Related Stomatitis , a randomized controlled trial
Scientific Title:Acronym
Oral Cooling (Cryotherapy),an Effective Treatment for prevention of Chemotherapy-Related Stomatitis , a randomized controlled trial
Region
| Japan |
Condition
Condition
Malignant Lymphoma
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
OralCooling(Cryotherapy),an Effective Treatment for prevention of Chemotherapy-Related Stomatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Outcome measure was grade of stomatitis.
Key secondary outcomes
Secondary outcome measure was QOL scale points.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Oral Cryotherapy is done during chemotherapy.
Interventions/Control_2
Control group do not cryotherapy.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Human
Malignant Lymphoma
Inpatients ando outpatients of Chemotherapy(R-CHOP)
Aged 20 to 69 years
Performance Status 0-1
Key exclusion criteria
Who had a grade 3 -4 oral stomatitis at starting points.
Psychiatric problem
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zentaro Yamagata |
Organization
Interdisciplinary Graduate School of medicine and Engineering, University of Ymanashi
Division name
Department of Health Sciences
Zip code
Address
1110, Shimokato, Chuo-shi, Yamanashi
TEL
055-273-9566
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zentaro Yamagata |
Organization
Interdisciplinary Graduate School of medicine and Engineering, University of Yamanashi
Division name
Department of Health Sciences
Zip code
Address
1110, Shimokato, Chuo-shi, Yamanashi
TEL
055-273-9566
Homepage URL
zenymgt@yamanashi.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Interdisciplinary Graduate School of medicine and Engineering, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Yamanashi Prefectural Central Hospital
Name of secondary funder(s)
Yamanashi Prefectural University
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
山梨県立中央病院（山梨県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | 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
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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002955
