A Study of Acupuncture for Bortezomib or Thalidomide -Induced Peripheral Neuropathy in Patients With Multiple Myeloma or Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Improvement in peripheral neuropathy
研究概览
简要总结
A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this complication include drugs like gabapentin or pregabalin, which relieve symptoms only partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or thalidomide, which may compromise treatment outcome. This clinical study explores whether, by intervening early in its course using acupuncture, progression of PN can be reversed, stabilized or retarded thereby allowing continuation of treatment on schedule.
详细描述
- The acupuncture treatment will start after patients have received at least 3 weeks of Gabapentin or Pregabalin at adequate dose without improvement in PN
- Two sessions of acupuncture per week, each of 30minutes duration, will be administered for a total of 10 sessions over 5 weeks. The needling will be done by the designated acupuncturist for all patients, delivered with electrical stimulation at a defined frequency.
- A fixed set of acupoints will be applied which include both local and distant points, based on both symptoms of PN and classification of TCM syndrome. Some degree of flexibility with addition or reduction of acupoints is allowed based on clinical indication. The acupoints needled each session will be recorded.
- Assessment of efficacy 4.1 Objective response : A complete neurological examination will be done at commencement of acupuncture and at end of acupuncture.
In addition, a full nerve conduction test will be done at beginning of acupuncture and at the end of 10 sessions of acupuncture.
4.2 Subjective assessment A quality of life questionnaire (FACT/GOG-NTX v4) will be filled in by patients at enrolment, commencement, at the 6th session and at the end of 10 sessions of acupuncture.
4.3 Scoring With both objective and subjective assessment, a Total Neuropathy Score can be calculated at each time point as a quantitative measurement of the severity of PN
- Statistical considerations The statistical analysis specifies that a lower limit of the two-sided 90 percent confidence interval for the overall positive response that exceeded 10 percent would be considered to be evidence of significant efficacy of acupuncture in retarding Bortezomib or thalidomide induced PN. Allowing a confidence interval width of 30%, the sample size needed will be 34 patients. To allow for a 10% drop-out, we plan to recruit a total of 40 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
- •Patients must have neuropathy greater or equal to 2 according to CTCAE v 3.0 scale in spite of adequate duration (at least 3 weeks) of previous treatment with Gabapentin or Pregabalin or are unable to tolerate these drugs. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed.
- •The patient's current or previous treatment must include bortezomib or thalidomide
- •ECOG Performance Status of 0, 1, or 2
排除标准
- •Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of active infection.)
- •Thrombocytopenia (platelet counts < 50x 109/L) on the day of acupuncture session
- •Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
- •Concurrent use of anticoagulation agents.
- •Known coagulopathy and taking heparin (including low molecular weight heparin) or warfarin at any dose. Patients on aspirin or non-steroidal anti-inflammatories are allowed to participate.
- •Persistent absolute neutrophil counts of < 1 x 109/L
- •Active CNS disease.
- •Patients having a cardiac pacemaker.
- •Currently pregnant or lactating females.
- •Severe diabetic neuropathy or neuropathy related to HIV.
- •Previous acupuncture treatment for any indication within 30 days of enrollment.
结局指标
主要结局
Improvement in peripheral neuropathy
时间窗: within the 5 weeks of acupuncture treatment
次要结局
未报告次要终点