UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Rikkunshito on Nausea, Vomiting and Anorexia in Patients with Uterus Cancer Treated with Cisplatin plus Paclitaxel - Randomized Phase II Study
Title of the study (Brief title)	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	Shunsuke Ohnishi, MD, PhD
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine
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	Hidemichi Watari, MD, PhD
Organization	Hokkaido University Hospital
Division name	Dpartment of Gynecology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://ejgo.org/DOIx.php?id=10.3802/jgo.2017.28.e44
Results
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