UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020383
Receipt number R000023499
Scientific Title Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer
Date of disclosure of the study information 2015/12/29
Last modified on 2019/06/21 09:31:05

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Basic information

Public title

Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer

Acronym

Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer

Scientific Title

Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer

Scientific Title:Acronym

Randomized phase II study of Hangeshashinto(TJ-14) for chemotherapy induced oral mucositis in patients with digestive cancer

Region

Japan


Condition

Condition

Digestive cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

DTM:Duration time of oral mucositis for 21 days.

Key secondary outcomes

Incidence of oral mucostis, Incidence of diarrhea, Blood level of CRP, Change of body weight and blood level of albumin


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Oral administration of Hangeshashinto 7.5g/day t.i.d. before meals.

Interventions/Control_2

No take Hangeshashinto.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with digestive cancer who undergo chemotherapy
2. Patients with oral mucositis caused by prior chemotherapy
3. ECOG Performance status : 0-1
4. Over 20 years old female
5. Patients who maintain main organs function
1) White blood cells count > 2,500/mm3 and < 12,000/mm3
2) Neutrophil count > 1,500/mm3
3) Platelet count > 10.0 X 10^4/mm3
4) AST,ALT > normal limit X 2.5
5) Serum total bilirubin < normal limit X 1.5
6) Serum creatinine < normal limit
6. Written informed consent

Key exclusion criteria

1. Patients who receives a medical prescription of herbal medicine within 2 weeks before registration of the final examination
2. Patients with the past of severe medicine hyperesthesia or severe drug allergy
3. Anti-inflammation anodyne medicine, OPIOIDO or the patient who has a medical treatment by a steroid
4.Sense unusualness or perception, some incomplete patients
5. Patients with active double cancer
6. Patients with serious heart diseases
7. Patients with serious lung diseases
8. Patients with serious constipation
9. Pregnant woman, lactating woman and patient with a possibility of the pregnancy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Gotoh

Organization

Osaka Medical College Hospital

Division name

Cancer Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, Japan

TEL

072-683-1221

Email

in2030@osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayuki Kii

Organization

Osaka Medical College Hospital

Division name

Cancer Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, Japan

TEL

072-683-1221

Homepage URL


Email

in2058@osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japanese


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

大阪医科大学附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 29 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

Completed

Date of protocol fixation

2015 Year 08 Month 04 Day

Date of IRB

2015 Year 11 Month 02 Day

Anticipated trial start date

2016 Year 01 Month 05 Day

Last follow-up date

2018 Year 06 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 28 Day

Last modified on

2019 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name