UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035864 |
|---|---|
| Receipt number | 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 10:59:06 |
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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
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
s_hirano@e-miz.co.jp
Sponsor or person
Institute
Clinic C4, Incorporated Medical Institution Yukokai
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040858
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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