NCT01892852Unknown不适用
Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline
研究概览
简要总结
The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma.
- •Patients must have chemotherapy-induced peripheral neuropathy greater or equal to 2 according to CTCAE (Common Terminology Criteria for Adverse Events) v 3.0 scale (Appendix A) in spite of previous conventional medications, e.g. Neurontin, Cymbalta and/or Lyrica. Patients receiving any of conventional medication for this symptoms must remain on the same medications throughout the study period.
- •Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent.
- •ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, or
- •If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception.
排除标准
- •Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV.
- •Current active treatment for lymphoma or multiple myeloma
- •Ongoing local infection at or near the acupuncture point adopted in this trial.
- •Severe immunocompromised patients, leukopenia ( < 4,000/㎣) or neutropenia ( < 1,500/㎣)
- •Known coagulopathy, thrombocytopenia (< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose.
- •Serious emotional or mental problems that precludes study entry.
- •Mental and physical disability that precludes accurate acupuncture.
- •Serious systemic diseases such as active infection, severe heart disease, uncontrolled hypertension and diabetes mellitus.
- •Cardiac pacemaker.
- •Pregnant or breastfeeding
- •Acupuncture therapy within the previous 30 days
- •Concurrent other complementary and alternative therapy such as herbal agents, high dose vitamins, and etc.
结局指标
主要结局
Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline
时间窗: At baseline, 1, 2, 3, and 7 wks from baseline
次要结局
- Change of VAS (Visual Analogue Scale) from baseline(At baseline, 1, 2, 3, and 7 wks from baseline)
- Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline(At baseline, 1, 2, 3, and 7 wks from baseline)
- Adverse events(From study enrollment to the last follow-up (up to 7 wks))
研究者
研究点 (2)
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