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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004287 |
Receipt No. | R000005135 |
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). |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2018/09/20 |
Basic information | ||
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 |
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Condition | |||
Condition | Colorectal Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
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 |
Assessment | |
Primary outcomes | Incidence of oral mucositis. grade>=2 |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
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 |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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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 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Aichi Medical University | ||||||
Division name | Cancer Center | ||||||
Zip code | |||||||
Address | 1-1, Yazakokarimata, Nagakute, Aichi | ||||||
TEL | 0561-62-3311 | ||||||
hmishima@aichi-med-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
chigusa.abe@ecrin.or.jp |
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 | Non profit foundation |
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IRB Contact (For public release) | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005135 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |