UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049103 |
|---|---|
| Receipt number | R000055930 |
| Scientific Title | A double-blind randomized controlled trial to verify the improvement effect of Hangeshashinto on oral mucositis and blood metabolome analysis to clarify biomarkers, Kampo medicine's proof, and to contribute to appropriate use of Kampo medicines |
| Date of disclosure of the study information | 2022/10/04 |
| Last modified on | 2023/10/04 11:32:15 |
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Basic information
Public title
A double-blind randomized controlled trial to verify the improvement effect of Hangeshashinto on oral mucositis and blood metabolome analysis to clarify biomarkers, Kampo medicine's proof, and to contribute to appropriate use of Kampo medicines
Acronym
Hange study
Scientific Title
A double-blind randomized controlled trial to verify the improvement effect of Hangeshashinto on oral mucositis and blood metabolome analysis to clarify biomarkers, Kampo medicine's proof, and to contribute to appropriate use of Kampo medicines
Scientific Title:Acronym
Hange study
Region
| Japan |
Condition
Condition
Head and Neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology | Oral surgery |
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of hangeshashinto in shortening the duration of radiation-induced oral mucositis in patients undergoing chemotherapy for head and neck cancer. At the same time, a metabolome analysis of the blood of the target patients will be performed over time, and the metabolic pathways that will lead to the elucidation of the mechanism of action of hangeshashinto and the components that are strongly related to the efficacy and can be used to predict the effect in advance (biomarkers, so-called Identify metabolites that lead to the visualization of Kampo medicine's proof.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration time of oral mucositis (DTM) of grade 2 or higher oral mucositis (assessed by CTCAE V5.0) during head and neck chemoradiation therapy.
Key secondary outcomes
The incidence of Grade 2 or higher oral mucositis (IOM) during head and neck chemoradiation therapy. Note that the grade is not the average intraday variation, but the worst grade within the day.
Time to healing of oral mucositis (THM)
Adverse events other than oral mucositis (oral bleeding, oral infectious complications, etc.) (frequency, severity)
Influence on treatment of primary disease
Proportion of discontinuation of radiotherapy
Percent reduction in chemotherapy intensity
Nutritional evaluation
Content and amount of oral intake
Percentage requiring nutritional management such as enteral nutrition through gastrostomy or high-calorie transfusion
Percentage of weight loss, percentage of decrease in blood prealbumin level
Metabolome analysis in blood
Chronological and exhaustive search for minute metabolites in blood
Safety evaluation of hangeshashinto and placebo
Presence or absence and frequency of adverse events due to the use of the study drug.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gargling with hangeshashinto and oral administration during head and neck chemoradiotherapy
Interventions/Control_2
Gargling with placebo and oral administration during head and neck chemoradiotherapy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with head and neck cancer undergoing chemoradiation therapy with an oral irradiation dose exceeding 30 Gy. (3) Patients whose performance status (ECOG classification) is 0 or 1 (4) Patients who are 18 years of age or older at the time of enrollment (5) Patients who have obtained a signed and dated consent form by the patient before enrollment in this study. (If the patient cannot write, obtain verbal consent and have a scribe write it on their behalf)
Key exclusion criteria
(1) Patients who have received kampo medicines preparations within 2 weeks prior to enrollment in this study (2) Patients who have a history of allergy to kampo medicines (3)Patients who are judged to be unsuitable for the safe conduct of this study by the research co-investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Ueno |
Organization
National Cancer Center Hospital
Division name
Department of Dentistry
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3548-2511
taueno@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Ueno |
Organization
National Cancer Center Hospital
Division name
Department of Dentistry
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3548-2511
Homepage URL
taueno@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Department of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ncc.go.jp
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055930
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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