UMIN-CTR Clinical Trial

Public title

Phase II randomized study to investigate the effectiveness of Hangeshashinto(TJ-14) against chemoradiation-induced oral and pharyngeal mucositis

Acronym

A rondomized study to investigate the effectiveness of Hangeshashinto(TJ-14) against chemoradiation-induced oral mucositis

Scientific Title

Phase II randomized study to investigate the effectiveness of Hangeshashinto(TJ-14) against chemoradiation-induced oral and pharyngeal mucositis

Scientific Title:Acronym

A rondomized study to investigate the effectiveness of Hangeshashinto(TJ-14) against chemoradiation-induced oral mucositis

Region

Japan

Condition

head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the preventive effect of Hangeshashinto(TJ-14) for chemoradiation-induced mucositis in head and neck cancer patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Incidence of more than grade 3 oral mucositis by CTCAE Ver. 4.0

Key secondary outcomes

1) Rates of chemoradiation completion
2) Duration of presence of more than grade 3 oral mucositis
3) Days until incidence of more than grade 3 oral mucositis
4) Total dose of opioids
5) Change of body weight
6) Nutrition status
7) Use of tube feeding
8) Grade of Dry mouth by CTCAE version 4.0 more than 6 months after chemoradiation

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of Hangeshashinto(TJ-14) during chemoradiation for more than 6 weeks other than basic supportive cares for oral mucositis.

Interventions/Control_2

Only basic supportive cares for oral mucositis.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Stage II-IVB oral, pharyngeal or laryngeal patients.
2) Patients who undergo chemoradiatio with cisplatin of more than 60 Gy for whole neck.
3) Patients who can take Hangeshashinto (TJ-14) by mouth.
4) Performance status 0 or 1.
5) Patients meeting all crietia below in the laboratory data within 7 days before starting chemoradiation.
WBC; more than 4,000/mm3,
Neutrophil count; more than 1,500/mm3
Platelet count; more than 100,000/mm3
BUN, ALT, AST; less than facility criteria
Creatinin clearance or correction eGFR
;less than 60ml/min
6) Inpatients.

Key exclusion criteria

1) Patients administered other Kampo medicine within 2 weeks before registration
2) Patients who were continuously adminisiterd NSAIDs, opioids or steroids within one month before registration
3) Patients having serious comorbid disease
4) Patients administered a developing new drug
5) Pregnant patients

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Akihiro Shiotani

Organization

National Defense Medical College of Japan

Division name

Department of Otolaryngolory-Head and Neck Surgery

Zip code

Address

3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan

TEL

+81-4-2995-1686

Email

ashiotan@ndmc.ac.jp

Name of contact person

1st name
Middle name
Last name	Taku Yamashita

Organization

National Defense Medical College of Japan

Division name

Department of Otolaryngolory-Head and Neck Surgery

Zip code

Address

3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan

TEL

+81-4-2995-1686

Homepage URL

Email

tkym@ndmc.ac.jp

Institute

Department of Otolaryngolory-Head and Neck Surgery, National Defense Medical College of Japan

Institute

Department

Personal name

Organization

Department of Otolaryngolory-Head and Neck Surgery, National Defense Medical College of Japan

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

防衛医科大学校病院（埼玉県）、神奈川県警友会けいゆう病院（神奈川県）、済生会宇都宮病院（栃木県）、さいたま市立病院（埼玉県）、佐野厚生総合病院（栃木県）、独立行政法人国立病院機構栃木医療センター（栃木県）、横浜市立市民病院（神奈川県）

Date of disclosure of the study information

2014

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

01

Month

22

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

01

Month

24

Day

Last modified on

2014

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015133