Unique ID issued by UMIN | UMIN000007974 |
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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 |
Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To assess the treatment effect of pregabalin and etodolac in patients with chemotherapy-induced peripheral neuropathy (CIPN).
Efficacy
Not applicable
Pain severity at 8 weeks after baseline (VAS, a self-administered questionnaire) (comparison with baseline)
- 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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
NO
Numbered container method
2
Treatment
Medicine |
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.
Etodolac group:
2 tablets, BID. Dose may be increased up to 800 mg depending on the patient' s symptoms.
20 | years-old | <= |
Not applicable |
Female
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
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
144
1st name | |
Middle name | |
Last name | Toyoshi Hosokawa |
University Hospital, Kyoto Prefectural University of Medicine
Departments of Pain Treatment and Palliative Care Unit
465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-8566
075-251-5177
hosobon@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Midori Morita |
Kyoto Prefectural University of Medicine
Department of Endocrine and Breast Surgery
465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-0841
0752515534
midori@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
None
Self funding
None
NO
京都府立医科大学附属病院(京都府)
2012 | Year | 05 | Month | 17 | Day |
Unpublished
Terminated
2011 | Year | 06 | Month | 02 | Day |
2011 | Year | 07 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2012 | Year | 05 | Month | 17 | Day |
2018 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009388
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