UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011227 |
|---|---|
| Receipt number | R000013155 |
| Scientific Title | Efficacy of Rikkunshito on Nausea, Vomiting and Anorexia in Patients with Uterus Cancer Treated with Cisplatin plus Paclitaxel - Randomized Phase II Study |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2017/05/31 18:09:22 |
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Basic information
Public title
Efficacy of Rikkunshito on Nausea, Vomiting and Anorexia in Patients with Uterus Cancer Treated with Cisplatin plus Paclitaxel - Randomized Phase II Study
Acronym
Efficacy of Rikkunshito on Nausea, Vomiting and Anorexia in Patients with Uterus Cancer Treated with Cisplatin plus Paclitaxel - Randomized Phase II Study
Scientific Title
Efficacy of Rikkunshito on Nausea, Vomiting and Anorexia in Patients with Uterus Cancer Treated with Cisplatin plus Paclitaxel - Randomized Phase II Study
Scientific Title:Acronym
Efficacy of Rikkunshito on Nausea, Vomiting and Anorexia in Patients with Uterus Cancer Treated with Cisplatin plus Paclitaxel - Randomized Phase II Study
Region
| Japan |
Condition
Condition
Uterus cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Rikkunshito on nausea, vomiting and anorexia caused by anti-cancer drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complete control rate (no emetic episodes, use of no rescue medications with mild nausea or no nausea) during the 5-day period postcisplatin
Key secondary outcomes
Complete response rate (no emetic episodes and use of no rescue medications), total control rate, time to treatment failure, appetite (VAS), nausea (VAS), FAACT anorexia and cachexia subscale scores, EORTC-QLQ-C30 scores, grade of appetite/nausea/vomiting byCTCAE v4.0, blood concentration of ghrelin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
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
| Medicine |
Interventions/Control_1
PTX 135 mg/m2 day0 or day1, or 175 mg/m2 day1 iv,
CDDP 50 mg/m2 day1 iv,
Granisetron 3 mg/body, day0 and 1 iv,
Aprepitant 125 mg day1 po, 80 mg day2, 3 po and
Dexamethasone 9.9 mg day1 iv, 6.6 mg day2 to 4 iv
(16.5mg day0 iv if PTX is administrated in day0.)
Interventions/Control_2
PTX 135 mg/m2 day0 or day1, or 175 mg/m2 day1 iv,
CDDP 50 mg/m2 day1 iv,
Granisetron 3 mg/body, day0 and 1 iv,
Aprepitant 125 mg day1 po, 80 mg day2, 3 po and
Dexamethasone 9.9 mg day1 iv, 6.6 mg day2 to 4 iv
(16.5mg day0 iv if PTX is administrated in day0.)
Rikkunshito 7.5g/day, day0-13, po
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
Female
Key inclusion criteria
1) Pathologically diagnosed uterus cancer
2) Patients who voluntarily signed the Institutional Review Board approved written informed consent
3) The uterus cancer notification was given
4) Expected to survive => 3 months
5) Age 20 or older
6) Eastern Cooperative Oncology Group (ECOG) Performance Status Grade of 0 to 2
7) Patients are scheduled to be treated with CDDP and paclitaxel as a first line chemotherapy
8) Patients who are able to take meals orally
9) Laboratory test results within these ranges
1. White blood cell count=>3,000/microliter and <=12,000/microliter
2. Neutrophils=>1,500/microliter
3. Platelets=>100,000/microliter
4. Hemoglobin=>8.0 g/dL
5. AST<=2x upper limit
6. ALT<=2x upper limit
7. Total bilirubin<=2.0 mg/dL
8. K=>3.0 mEg/L
9. Creatinine clearance=>60 mL/min
10. No abnormality in echocardiography
Key exclusion criteria
1)Patients with cerebral metastases
2)Patients with double cancer
3)Patients with seizure disorder requiring anticonvulsants
4)Patients with disturbed consciousness
5)Patients with gastrointestinal obstruction
6)Patients with vomiting or nausea with =>CTCAE v4.0 Grade 2
7)Patients participating in any other clinical trial
8)Patients with uncontrollable hypertension
9)Patients with diabetes mellitus treated with insulin, or uncontrollable diabetes mellitus
10)Patients with taking corticosteroid, androgen, progesterone or any other orexigenic medicine
11)Patients treated with opioids
12)Pregnant woman, Nursing woman, and woman not to agree with contraception
13)Patients with infection requiring systemic treatment
14)Patients having body temperature of =>38 degree at the enrollment
15)Patients with psychiatric disorder or any psychiatric symptoms, and considered in ineligible to the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Ohnishi, MD, PhD |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medicine
Zip code
Address
N15, W7, Kita-ku, Sapporo 060-8638 JAPAN
TEL
+81-11-716-2111
sonishi@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemichi Watari, MD, PhD |
Organization
Hokkaido University Hospital
Division name
Dpartment of Gynecology
Zip code
Address
N14, W5, Kita-ku, Sapporo 060-8648 JAPAN
TEL
+81-11-706-5941
Homepage URL
watarih@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
北海道大学病院（北海道）
北海道がんセンター（北海道）
王子総合病院（北海道）
岩手医科大学（岩手）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://ejgo.org/DOIx.php?id=10.3802/jgo.2017.28.e44
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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 29 | 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
| 2013 | Year | 07 | Month | 18 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013155
