UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Title of the study (Brief title)	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	Toyoshi Hosokawa
Organization	University Hospital, Kyoto Prefectural University of Medicine
Division name	Departments of Pain Treatment and Palliative Care Unit
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	Midori Morita
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrine and Breast Surgery
Address	465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-0841
TEL	0752515534
Homepage URL
Email	midori@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 06 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009388