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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011227
Receipt No. 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

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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
Obsterics 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
Email 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
Email watarih@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013155

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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