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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004214
Receipt No. R000005060
Scientific Title Phase II, Randomized, Double-Blind ,Placebo-Controlled Study of Hangeshashinto for Prevention of Oral Mucositis in Gastric Cancer Patients Receiving Chemotherapy (HANGESHA-G Study).
Date of disclosure of the study information 2010/10/01
Last modified on 2014/10/15

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Basic information
Public title Phase II, Randomized, Double-Blind ,Placebo-Controlled Study of Hangeshashinto for Prevention of Oral Mucositis in Gastric Cancer Patients Receiving Chemotherapy (HANGESHA-G Study).
Acronym Study of Hangeshashinto for Prevention of Oral Mucositis in Gastric Cancer Patients Receiving Chemotherapy (HANGESHA-G Study).
Scientific Title Phase II, Randomized, Double-Blind ,Placebo-Controlled Study of Hangeshashinto for Prevention of Oral Mucositis in Gastric Cancer Patients Receiving Chemotherapy (HANGESHA-G Study).
Scientific Title:Acronym Study of Hangeshashinto for Prevention of Oral Mucositis in Gastric Cancer Patients Receiving Chemotherapy (HANGESHA-G Study).
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of Hangeshashinto compared with placebo for prevention and treatment of oral mucositis in gastric cancer patients receiving chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of CTCAE grade 2 <= oral mucositis.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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. before meals or between meals.
Interventions/Control_2 Oral administration of placebo 7.5g/day t.i.d. before meals or between 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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Chemotherapy receiving.
(2)Developed oral mucositis right before chemotherapy.
(3)ECOG P.S. of 0, 1 or 2.
(4)Age of at least 20 years at registration.
(5)A life expectancy of more than 12 weeks.
(6)Adequate function of vital organs, as evidenced by the following data within 7 days before registration:
hematopoietic function
white blood cell count >=2,500/mm3 and <= 12,000/mm3.
neutrophil count >= 1.500/mm3.
platelet count >= 100,000/mm3.
liver function
aspartate aminotransferase and alanine aminotransferase levels less than 2.5 times the institutional upper limit of normal.(with liver metastasis less than 5 times)
total bilirubin level less than 1.5 times the institutional upper limit of normal.
renal function
serum creatinine level below the institutional upper limit of normal.
(7)All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria (1)Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration.
(2)Patients who had used traditional Japanese medicines (Kampo) within 2 weeks before registration.
(3)History of severe hypersensitivity (allergy) to any medicines.
(4)Patients who had received antiphlogistic analgetic, opioid, or steroid.
(5)Prior or current therapy for neuropathy or sensory dysfunction.
(6)Other active malignancies.
(7)Uncontrolled pleural effusion or ascites.
(8)A systemic inflammatory condition or serious infection.
(9)Brain metastasis.
(10)Significant electrocardiographic abnormality.
(11)Clinically problematic cardiac disease (congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, or myocardial infarction within the past 12 months).
(12)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, etc.).
(13)Gastrointestinal bleeding that requires medication or transfusion.
(14)Diarrhea (watery) or diarrhea that interferes with daily activities for patients with a stoma.
(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.
(21)Serious constipation.
(22)Pregnant or lactating women.
(23)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tsuburaya
Organization Kanagawa Cancer Center
Division name Gastro-Intestinal Surgery
Zip code
Address 1-1-2, Asahi-ku, Yokohama, Japan
TEL 045-391-5761
Email tuburayaa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Tsuburaya
Organization Kanagawa Cancer Center
Division name Gastro-Intestinal Surgery
Zip code
Address 1-1-2, Asahi-ku, Yokohama, Japan
TEL 045-391-5761
Homepage URL
Email tuburayaa@gmail.com

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization NPO Epidemiological and Clinical Research Information Network (ECRIN)
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 神奈川県立がんセンター(神奈川),大阪府立急性期総合医療センター(大阪),千葉県がんセンター(千葉),広島大学病院(広島),広島大学病院(広島),近畿大学医学部(大阪),帝京大学医学部(東京),市立豊中病院(大阪),広島市立安佐市民病院(広島),高知大学医学部(高知),静岡県立総合病院(静岡),京都北逓信病院(京都),箕面市立病院
(大阪),名古屋医療センター(名古屋),名古屋市立大学(名古屋),愛知県がんセンター愛知病院(愛知)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://link.springer.com/article/
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 No longer recruiting
Date of protocol fixation
2010 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 17 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 22 Day
Date trial data considered complete
2013 Year 08 Month 20 Day
Date analysis concluded
2013 Year 08 Month 20 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 15 Day
Last modified on
2014 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005060

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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