UMIN-CTR Clinical Trial

Public title

Open Label Study of Hangeshashinto for Prevention of Chemotherapy Induced Adverse Effect (Oral Mucositis) in Head and Neck Cancer.

Acronym

Clinical Study of Hangeshashinto for Prevention of Chemoradiotherapy Induced Oral Mucositis in Head and Neck Cancer.

Scientific Title

Open Label Study of Hangeshashinto for Prevention of Chemotherapy Induced Adverse Effect (Oral Mucositis) in Head and Neck Cancer.

Scientific Title:Acronym

Clinical Study of Hangeshashinto for Prevention of Chemoradiotherapy Induced Oral Mucositis in Head and Neck Cancer.

Region

Japan

Condition

Oropharyngeal or hypopharyngeal squamous cekk carcinoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate efficacy (the prevention / curative effect) and safety of TJ-14 for chemoradiotherapy induced oral mucositis in head and neck cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of mucositis (more than grade 1)

Key secondary outcomes

Nutrition index
Opioid use
Use of feeding tube
Oral pain

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with histologically or cytologically confirmed squamous cell carcinoma of oropharynx or hypopharynx.
2) Patients who will receive chemotherapy and radiotherapy.
3) Patients who can take TJ-14
4) An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5) Age more than or equal to 20 years at the time of providing informed consent.
6) A life expectancy of more than 12 weeks from.
7) Confirmed by the following data obtained in the 7 days before registration.
hematopoietic function
white blood cell count over 4,000/mm3.
neutrophil count over 1.500/mm3.
platelet count over 100,000/mm3.
renal function
urea nitrogen level below the institutional upper limit of normal.
serum creatinine level below the institutional upper limit of normal or creatinine clearance over 60 ml/min
liver function
aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase levels less than 2 times the institutional upper limit of normal.
8) Patients who will be Hospitalized
9) Written informed consent before initiation of study related procedures.

Key exclusion criteria

1) Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders etc.).
2) Patients who had used traditional Japanese medicines (Kampo) within 2 weeks before registration.
3) Patients who had received antiphlogistic analgetic, opioid, or steroid continuously within 1 month before registration.
4) Patients with planning or during treatment of investigational drug.
5) Chronic constipation.
6) Patients with pregnant, considering pregnancy or lactation.
7) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Fukuda

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code

Address

Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638 Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Hokkaido University Hospital

Division name

Department of Otolaryngology

Zip code

Address

TEL

Homepage URL

http://www.huhp.hokudai.ac.jp/patient/sec/jibiinkouka/index.html

Email

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

None

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

Date of disclosure of the study information

2011

Year

10

Month

03

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

Preinitiation

Date of protocol fixation

2011

Year

07

Month

27

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

03

Day

Last modified on

2011

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007239