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

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 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


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

Value
https://center6.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