UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013281
Receipt number R000015461
Scientific Title Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.
Date of disclosure of the study information 2014/03/03
Last modified on 2014/02/26 13:42:31

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Basic information

Public title

Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.

Acronym

Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.

Scientific Title

Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.

Scientific Title:Acronym

Comparative study of effectiveness gargling "Hange-shashin-to" and azulene sodium sulfonate for oral mucositis which associated with cancer therapy.

Region

Japan


Condition

Condition

head and neck cancer, oral cancer

Classification by specialty

Medicine in general Hematology and clinical oncology Oto-rhino-laryngology
Radiology Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

"Hange-shashin-to" was widely used in neurological gastritis, nausea and dyspepsia. This medicine have a indication for oral mucositis because of these anti-inflammatory effect when we take it for internal use. Preventive effect of gargling "Hange-shashin-to" for oral mucositis was not verified.
We planned to validate of efficacy of gargling "Hange-shashin-to" about patients who contracted head and neck cancer and oral cancer which are scheduled chemotherapy or chemoradiotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Objective evaluation: CTCAE ver.4.0, food requirement, blood examination(total protein, albumin, inflammatory cytokine, etc)
Subjective assesment: patients questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

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

Control group: Patients gargles with azulene sodium sulfonate three times a day since treatment start.

Interventions/Control_2

Hange-shashin-to group: Patients gargles with Hange-shashin-to three times a day since treatment start.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients, who suffered from oral cancer or head and neck cancer, planned chemotherapy and chemoradiotherapy.

Key exclusion criteria

The patients uses gargling before treatment.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nodoka Sekiguchi

Organization

Shinshu University

Division name

Department of Comprehensive Cancer Therapy

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-35-4600

Email

nodokas@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nodoka Sekiguchi

Organization

Shinshu University

Division name

Department of Comprehensive Cancer Therapy

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-35-4600

Homepage URL


Email

nodokas@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Shinshu University Hospital

Organization

Division

Category of Funding Organization

Other

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

2014 Year 03 Month 03 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

Preinitiation

Date of protocol fixation

2014 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 26 Day

Last modified on

2014 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name