UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008080
Receipt number R000008312
Scientific Title Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.
Date of disclosure of the study information 2012/06/01
Last modified on 2019/06/08 14:43:57

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Basic information

Public title

Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.

Acronym

Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting.

Scientific Title

Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.

Scientific Title:Acronym

Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting.

Region

Japan


Condition

Condition

head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Examination concerning dosage of dexamethasone when Fosaprepitant and Palonosetron are used together for nausea and vomiting induced chemotherapy for head and neck cancer.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Complete response rate of vomiting within 120hours from cisplatin administration

Key secondary outcomes

(a)Complete response rate of vomiting within 24hours,and 24-120 hours from cisplatin administration.
(b)Level of nausea
(c)Level of anorexia
(d)The proportion of patients receiving rescue medication.
(e)Evaluation of nausea and vomiting of each course on 10 point scale.
(f)adverse event


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Fosaprepitant 150mg, iv (Day 1)
Palonosetron 0. 75mg, iv (Day 1)
Dexamethasone 9.9 mg, iv (Day 1)
Dexamethasone 6.6 mg, iv (Days 2-4)

Interventions/Control_2

Fosaprepitant 150mg, iv (Day 1)
Palonosetron 0. 75mg, iv (Day 1)
Dexamethasone 3.3 mg, iv (Days 1-4)

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(a) From 20 or more to 75 years old or less at time of registration.
(b) Patients who receive the chemotherapy by two courses involving cisplatin as first line.
(c) ECOG PS of patients is 0-2.
(d) Patients will provide written informed consent.

Key exclusion criteria

(a) Vomiting prior to chemotherapy within 24hours
(b) They have the factor (tumor of the brain, street trouble of the gut, ulcus pepticum of briskness, and cerebral metastasis, etc.) that nausea and vomiting are caused besides the cancer chemotherapy
(c) They have an associated symptom (ex infectious disease) patient who cannot administer dexamethasone.
(d) judged by the investigator to be inappropriate for this study
(e) pimozide is being administered.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Katsuhiro
Middle name
Last name Hirakawa

Organization

Hiroshima University Hospital

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code

7348551

Address

Kasumi 1-2-3 Minami-ku, Hiroshima

TEL

082-257-5252

Email

katsuhw@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Tsutomu
Middle name
Last name Ueda

Organization

Hiroshima University Hospital

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code

7348551

Address

Kasumi 1-2-3 Minami-ku, Hiroshima

TEL

082-257-5252

Homepage URL


Email

uedatsu@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital Department of Otorhinolaryngology Head and Neck Surgery

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University Hospital Department of Otorhinolaryngology Head and Neck Surgery

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

Hiroshima University Ethics Review Board

Address

Kasumi 1-2-3 Minami-ku, Hiroshima

Tel

082-257-5596

Email

hugcp@hiroshima-u.ac.jp


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

2012 Year 06 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

Completed

Date of protocol fixation

2011 Year 10 Month 18 Day

Date of IRB

2012 Year 05 Month 31 Day

Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 06 Month 01 Day

Last modified on

2019 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name