KCT0005654尚未招募未知
Efficacy and safety of Combined Therapeutics(Electroacupuncture and Musical Therapy) for Chemotherapy Induced Peripheral Neuropathy : A Randomized, Assessor-blinded, Controlled, Pilot Trial protocol
Kyung Hee University Oriental Medical Center0 个研究点目标入组 46 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •[Inclusion criteria]
- •: must include all of the following conditions
- •1) Over 19 years old, male and female
- •2) Diagnosed with solid cancer(Stage 1 to 3)
- •3) Those who have completed chemotherapy* as from the date of visit to screening
- •* Platinum-based or taxane-based drug or their combined chemotherapy
- •4) Diagnosed with CIPN
- •5) A person with pain score of 4 or more due to CIPN measured by the Average Score of BPI-SF(Breef Pain Index-Short Form).
- •6) A person whose ECOG(the Eastern Cooperative Oncology Group) performance status is 0 or 1.
- •7) A person whose life expectancy is more than six months.
- •8) A person who voluntarily agrees to participate in this clinical trial
排除标准
- •[Exclusion criteria]
- •: must exclude all of the following conditions
- •1) A person who has peripheral neuropathic pain due to other causes other than CIPN (Diabetic peripheral neuropathy, Post-herpetic neuralgia, Complex regional pain syndrome, HIV related neuropathy or Post-traumatic/Post-operative peripheral neuropathy, etc.).
- •2) A person who has more severe side effects than pain after chemotherapy is completed (Tissue necrosis, Gastrointestinal toxicity, Nephrotoxicity, cardiotoxicity, etc.).
- •3) A person with central neuropathic pain (spinal cord injury, Central post-stroke pain, Neuropathic pain or Multiple sclerosis, etc.)
- •4) A person with infection, severe heart failure or severe pulmonary as from the date of visit to screening
- •5) A pregnant woman and breast-feeding woman
- •6) Those who are taking prohibited drugs or who need prohibited drugs during clinical trials as from the date of visit to screening (Refer to #7.(2) Prohibit from doing together), Only the following can be enrolled.
- •* A drug being taken for the treatment of CIPN such as Tricyclic antidepressants (Ex.Gabapentin), Pregabalin, etx.
- •- A person who can maintain stable condition without changing the class, dose, usage of drugs during clinical trials 4 weeks before the date of visit to screening visit.
- •* Non-opioid analgesics and Corticosteroid
- •- A person who agrees to discontinue medication during a clinical trial and has a wash out period for two weeks before randomization
- •- A person who can maintain stable condition without changing the class, dose, usage of drugs during clinical trials 2 weeks before the date of visit to screening visit.
- •* Bisphosphonate
- •- A person who can maintain stable condition without changing the class, dose, usage of drugs during clinical trials 6 months before the date of visit to screening visit.
- •7) A person whose hematological findings correspond to the following conditions:
- •- AST, ALT > 3 times the upper limit of normal range
- •- Creatinine > 1.5 times the upper limit of normal range
- •- Bilirubin > 1.5 times the upper limit of normal range
- •- WBC < 3,000/mm3
- •- Platelet < 75,000/mm3
- •8) A person whose ability to read, understand, and write letters has been significantly reduced, making it difficult to assess his/her own pain.
- •9) A person who is scheduled to undergo operation or radiotherapy within 10 weeks of randomization.
- •10) A person who is scheduled for additional chemotherapy during this clinical trial period
- •11) A person who has participated in another clinical trial within 1 month of the beginning of this clinical trial or plans to participate in another clinical trial during this clinical trial.
- •12) Any other person decided inappropriate by clinical investigator to participate in this clinical trial
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