UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015872
Receipt number R000018472
Scientific Title Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.
Date of disclosure of the study information 2014/12/08
Last modified on 2017/06/09 09:29:31

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Basic information

Public title

Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.

Acronym

Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer

Scientific Title

Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.

Scientific Title:Acronym

Effect and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer

Region

Japan


Condition

Condition

Gastric cancer, breast cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of pregabalin and duloxetine on chemotherapy-related peripheral neurotoxicity for patients with advanced gastric and breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Proportion of patients who was improved FACT-Taxane after administering pregabalin or duloxetine.

Key secondary outcomes

1) Adverse effect of pregabalin and duloxetine
2) Investigation of QOL (FACT-Taxane)
3)Current perception threshold(CPT)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pregabalin is administered 75mg bid and increased gradually 150mg bid over 1week.

Interventions/Control_2

Duloxetine is administered 40mg qd.
To begin administering 20mg qd, duloxetine is increased 40mg qd after an interval of more than 1 week.

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

Male and Female

Key inclusion criteria

1) Patients who have diagnosed gastric or breast cancer by cytodiagnosis or histological diagnosis.
2) Patients who have chemotherapy -related neurotoxicity (Grade2:CTCAE v4.0) and pain.
3) ECOG PS of 0 or 1
4) Adequate function of vital organs
5) Satisfactory oral feeding
6) Written informed consent

Key exclusion criteria

1) Serious drug allergy
2) Active double cancer
3) Active infection
4) Serious coexisting illness
5) History of pregabalin and duloxetine treatment
6) Severe renal dysfunction
(Creatinine clearance <30mL/min)
7) Patients with using electronic implants or other cardiac pacemaker
8) Pregnant or lactating women or men who have desire father a child
9) Investigator's judgement

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashiro Goto

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN

TEL

072-683-1221

Email

in2030@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashiro Goto

Organization

Osaka Medical College Hospital

Division name

Chemotherapy Center

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN

TEL

072-683-1221

Homepage URL


Email

in2030@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College Hospital

Organization

Division

Category of Funding Organization

Self funding

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

大阪医科大学付属病院(Osaka Medical College Hospital)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 08 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

2014 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 10 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

2014 Year 12 Month 08 Day

Last modified on

2017 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018472


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name