Breast cancer
Conditions
Interventions
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 i
s symptoms.
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain severity at 8 weeks after baseline (VAS, a self-administered questionnaire) (comparison with baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Japan
Contacts
Public ContactMidori Morita
Kyoto Prefectural University of Medicine Department of Endocrine and Breast Surgery
Outcome results
None listed