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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002411
Receipt No. 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 2009/08/31

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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
Email

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
Email zenymgt@yamanashi.ac.jp

Sponsor
Institute Department of Health Sciences, Interdisciplinary Graduate School of medicine and Engineering, University of Yamanashi
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
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
2009 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002955

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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