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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000035864
Receipt No. R000040858
Scientific Title Retrospective observational study of hydrogen gas inhalation on side effect in cancer patients receiving radiation
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/13

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Basic information
Public title Retrospective observational study of hydrogen gas inhalation on side effect in cancer patients receiving radiation
Acronym Reducing effect of hydrogen gas inhalation on side effect in radiation
Scientific Title Retrospective observational study of hydrogen gas inhalation on side effect in cancer patients receiving radiation
Scientific Title:Acronym Reducing effect of hydrogen gas inhalation on side effect in radiation
Region
Japan

Condition
Condition Malignant Tumor and Bone Marrow Damage
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of our study is to examine the effect of hyperbaric hydrogen gas inhalation on bone marrow damage in end sage of cancer patients receiving radiotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone marrow damage before and after radiotherapy is evaluated by hematological examination.
Key secondary outcomes

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
100 years-old >=
Gender Male and Female
Key inclusion criteria none
Key exclusion criteria none
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukimasa Aoki
Organization Incorporated Medical Institution Yukokai
Division name Clinic C4
Zip code
Address 33-12 Motoyotogicho, Shibuya-ku, Tokyo, Japan
TEL 03-6407-9407
Email yaoki-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichi Hirano
Organization MiZ Co. Ltd.
Division name Department of Research and Development
Zip code
Address 2-19-15 Ofuna, Kamakura, Kanagawa, Japan
TEL 0467-53-7511
Homepage URL
Email s_hirano@e-miz.co.jp

Sponsor
Institute Clinic C4, Incorporated Medical Institution Yukokai
Institute
Department

Funding Source
Organization None
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
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
2019 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Radiotherapy without hyperbaric hydrogen inhalation significantly reduced white blood cells and platelets, but not red blood cells, hemoglobin and hematocrit. In contrast, radiotherapy with hyperbaric hydrogen gas inhalation significantly attenuated the reducing effects of white blood cells and platelets. The result of this study was reported at 7th Meeting of the Japanese Biomedical Association of Molecular Hydrogen (held on October, 2017).
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 Main results already published
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Hydrogen gas inhalation reduced the bone marrow damage in patients with radiotherapy.

Management information
Registered date
2019 Year 02 Month 13 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040858

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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