UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004214 |
|---|---|
| Receipt number | 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 17:20:12 |
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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
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
tuburayaa@gmail.com
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005060
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