ACTRN12617000139370招募中2 期
The use of duloxetine for the treatment of chemotherapy-induced peripheral neuropathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Daily symptoms of peripheral neuropathy for at least 3 months after completing chemotherapy.
- •2. History of neuropathic symptoms beginning in extremities following chemotherapy, e.g.: dysesthesia, burning pain, hyperalgesia of lower extremities, shooting or lancinating pain, aching, or tingling.
- •3. At least grade 1 sensory neuropathy via the National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI CTCAE) version 4.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- •5. Willingness and ability to give written informed consent, and willingness to participate in and comply with the study.
排除标准
- •1. Currently receiving chemotherapy, or have received chemotherapy within the last 3 months.
- •2. Inability to speak English.
- •3. Pregnancy or lactation. Contraception is required in pre-menopausal female patients.
- •4. Calculated creatinine clearance less than 60 mL/min.
- •5. AST (aspartate aminotransferase) greater than or equal to 3 times upper limit of normal (greater than or equal to 135 U/L).
- •6. Total bilirubin greater than 25 umol/L.
- •7. INR (international normalised ratio) greater than 1.4.
- •8. Diabetes mellitus, type 1 and 2.
- •9. HIV infection.
- •10. Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy.
- •11. Currently receiving active treatment for glaucoma.
- •12. Severe depression, suicidality, bipolar disorder, schizophrenia, major eating disorder, at the discretion of the treating clinician.
- •13. Alcohol abuse or dependence.
- •14. Current use of any class of antidepressant or antipsychotic medication. At least 14 days must have passed since last use of antidepressant medication. Medication should not have been discontinued without medical consultation.
- •15. Current use of CYP1A2 inhibitors, including:
- •- fluvoxamine
- •- ciprofloxacin
- •- enoxacin
- •- fluoroquinolones
- •- verapramil
- •- vemurafenib
- •- amiodarone
- •- interferon
- •- artemisinin
- •- atazanavir
- •16. Current use of anticoagulants.
- •17. Current treatment for peripheral neuropathy or neuropathic pain. Any treatments for these conditions must be ceased at least 14 days prior to randomisation.
研究者
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