UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007974
Receipt number R000009388
Scientific Title Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Date of disclosure of the study information 2012/05/17
Last modified on 2018/11/21 16:13:52

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Basic information

Public title

Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-

Acronym

Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-

Scientific Title

Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-

Scientific Title:Acronym

Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the treatment effect of pregabalin and etodolac in patients with chemotherapy-induced peripheral neuropathy (CIPN).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Pain severity at 8 weeks after baseline (VAS, a self-administered questionnaire) (comparison with baseline)

Key secondary outcomes

- VAS at every 4 weeks (except at 8 weeks)
- Severity of CIPN at every 4 weeks after baseline (PNQ) (comparison with baseline)
- CTCAE v4.0 at every 4 weeks after baseline (comparison with baseline)
- SF-36 at every 4 weeks after baseline (comparison with baseline)
- Questionnaire of pain due to numbness at every 4 weeks after baseline (comparison with baseline)
- Total dose, duration, and number of doses of paclitaxel
- Total dose of pregabalin, age, height, body weight, duration of the disease, laboratory values, disease stage, and concomitant medications
- Total dose of etodolac, age, height, body weight, duration of the disease, laboratory values, disease stage, and concomitant medications


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pregabalin group:
Dose start from 75mg, before bed. Dose could be increased to 150 mg, BID, and 2 weeks later, the dose may be increased to 300 mg, BID.

Interventions/Control_2

Etodolac group:
2 tablets, BID. Dose may be increased up to 800 mg depending on the patient' s symptoms.

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) Female patients aged 20 years or older (regardless of hospitalization status)
2) Breast cancer patients with Grade D or E in PNQ
The following items are rated on a 3-point scale (0: none, 1: somewhat applicable, 2: very applicable), and when >=2 items are rated 2, the neuropathy is regarded as Grade D.
Then the study treatment would proceed.
(a) Unable to open a plastic bottle
(b) Unable to button your clothes
(c) Cannot write
(d) Drop things
(e) Unable to put on shoes
(f) Stumble
3) Patients without peripheral neuropathy (such as numbness) or any underlying disease causing peripheral neuropathy before the treatment
4) Patients who are able to answer the questionnaires written in Japanese without assistance
5) Patients who are going to receive >=2 cycles of paclitaxel chemotherapy
6) Patients expected to survive for at least 4 months
7) Patients who agreed to participate in the study and signed informed consent form

Key exclusion criteria

1) Patients with a current or past history of gastrointestinal hemorrhage or peptic ulcer
2) Patients with a current or past history of serious complications such as cardiac, renal, hepatic, and hematological disorders
3) Patients with neuropathic pain due to diabetes mellitus or herpes zoster
4) Patients with a history of hypersensitivity to pregabalin or etodolac
5) Patients with neurological symptoms due to brain and/or bone metastases
6) Patients who used pregabalin or etodolac for treating pain possibly associated with paclitaxel
7) Other patients considered to be ineligible to participate in the study by the investigator

Target sample size

144


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toyoshi Hosokawa

Organization

University Hospital, Kyoto Prefectural University of Medicine

Division name

Departments of Pain Treatment and Palliative Care Unit

Zip code


Address

465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-8566

TEL

075-251-5177

Email

hosobon@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Midori Morita

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Endocrine and Breast Surgery

Zip code


Address

465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-0841

TEL

0752515534

Homepage URL


Email

midori@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


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

京都府立医科大学附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 17 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

Terminated

Date of protocol fixation

2011 Year 06 Month 02 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 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 05 Month 17 Day

Last modified on

2018 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009388


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name