UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015120 |
|---|---|
| Receipt number | R000017591 |
| Scientific Title | Pilot study of efficacy and safety of Rikkunshito for adverse events (nausea, emesis and anorexia) caused by chemotherapy (GD therapy) for high-grade soft tissue sarcomas. |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2014/09/11 14:25:22 |
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Basic information
Public title
Pilot study of efficacy and safety of Rikkunshito for adverse events (nausea, emesis and anorexia) caused by chemotherapy (GD therapy) for high-grade soft tissue sarcomas.
Acronym
Pilot study of Rikkunshito for adverse events caused by chemotherapy (GD therapy).
Scientific Title
Pilot study of efficacy and safety of Rikkunshito for adverse events (nausea, emesis and anorexia) caused by chemotherapy (GD therapy) for high-grade soft tissue sarcomas.
Scientific Title:Acronym
Pilot study of Rikkunshito for adverse events caused by chemotherapy (GD therapy).
Region
| Japan |
Condition
Condition
High-grade soft tissue sarcomas
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Rikkunshito on nausea, emesis and anorexia caused by anti-cancer drug
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nausea, emesis and anorexia (CTCAE ver4.0), EORTC QLQ-C30(version3)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rikkunnshito
7.5g/day, 14days
Interventions/Control_2
No Rikkunnshito
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with histologically-proved high-grade bone and soft tissue sarcoma
Patients firstly applied modified MAID regimen
Patients with healthy vital organs
WBC >3000/mm3 and <20000/mm3
Neutrophils >1500/mm3
Hb >8.0g/dl
Plat >8X104/mm3
Total Bil <2.0mg/dl
ALT/AST <150IU/l
Cr <1.5mg/dl
Performance Status (ECOG) 0-2
Key exclusion criteria
1. Patients with double cancer
2. Patients who took Kampo within 4 weeks
3. Patients with any other severe diseases
4. Pregnat patients
5. Other exclusionary comobidity
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Goto |
Organization
Tokyo Metropolitan Komagome Hospital
Division name
Department of Musculoskeletal Oncology
Zip code
Address
3-18-22, Hon-Komagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
goto-tky@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Goto |
Organization
Tokyo Metropolitan Komagome Hospital
Division name
Department of Musculoskeletal Oncology
Zip code
Address
3-18-22, Hon-Komagome, Bunkyo-ku, Tokyo
TEL
03-3823-2101
Homepage URL
goto-tky@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 11 | Day |
Last modified on
| 2014 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
