UMIN-CTR Clinical Trial

Public title

Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).

Acronym

Placebo-Controlled RPII Study of Hangeshashinto for Prevention of Oral Mucositis in CRC Pts Receiving Chemotherapy(HANGESHA-C Study).

Scientific Title

Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).

Scientific Title:Acronym

Placebo-Controlled RPII Study of Hangeshashinto for Prevention of Oral Mucositis in CRC Pts Receiving Chemotherapy(HANGESHA-C Study).

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy of Hangeshashinto for prevention and treatment of oral mucositis in colorectal cancer patients receiving chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Incidence of oral mucositis. grade>=2

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

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

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

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)Receiving chemotherapy.
(2)Oral mucositis in previous chemotherapy course.
(3)ECOG P.S. of 0 or 1.
(4)age of 20 years or older.
(5)A life expectancy of more than 12 weeks.
(6)Adequate function of vital organs, laboratory data within 7 days.
WBC >=3,000/mm3 and <=12,000mm3.
Neutrophil >=1,500/mm3
platelet >=100,000/mm3
AST and ALT
<=2.5 ULN or <=5.0 ULN if the patient has liver metastasis aspartate aminotransferase and alanine
T-Bil <=1.5 ULN
Cr <=UNL
(7)Written informed consent.

Key exclusion criteria

(1)blood transfusion or hemopoietic factors (e.g.G-CSF) within 7 days .
(2)Not using traditional Japanese medicines (Kampo) within 2 weeks.
(3)Serious drug allergy..
(4)Current analgesic treatment.
(5)Neuropathy or sensory dysfunction.
(6)Active double cancer.
(7)Uncontrolled pleural effusion or ascites.
(8)Clinically significant infection.
(9)Brain metastasis.
(10)Clinically significant electrocardiographic abnormality.
(11)Clinically significant heart disease (myocardial infarction within 12 months, etc.).
(12)Clinically significant pulmonary disease
(13)Gastrointestinal bleeding that requires medication or transfusion.
(14)Watery diarrhea..
(15)Myelosuppresion.
(16)Ileus or bowel obstruction.
(17)Central nervous system disorders.
(18)Dementia.
(19)Serious psychological disease.
(20)Uncontrolled diabetes mellitus with or without diabetic neuropathy.

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Mishima Hideyuki

Organization

Aichi Medical University

Division name

Cancer Center

Zip code

Address

1-1, Yazakokarimata, Nagakute, Aichi

TEL

0561-62-3311

Email

hmishima@aichi-med-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Chigusa Abe

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Division name

Data Center

Zip code

Address

21-7 Shogoinn Sakyo-ku, Kyoto

TEL

075-762-1227

Homepage URL

Email

chigusa.abe@ecrin.or.jp

Institute

NPO Epidemiological and Clinical Research Information Network (ECRIN)

Institute

Department

Personal name

Organization

NPO Epidemiological and Clinical Research Information Network (ECRIN)

Organization

Division

Category of Funding Organization

Non profit foundation

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

2010

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2010

Year

08

Month

24

Day

Date of IRB

Anticipated trial start date

2010

Year

10

Month

01

Day

Last follow-up date

2012

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

09

Month

28

Day

Last modified on

2018

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005135