Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
研究概览
简要总结
The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet and/or hands that is related to chemotherapy.
详细描述
Acupuncture:
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. In this study, the needles are placed in areas that are intended to help relieve numbness and tingling of the feet and hands. Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture.
Acupuncture Sessions:
Your first acupuncture session will be on the same day as the tests described above, if possible. (If not, it will be scheduled for another day that will be no more than about 10 days after the screening visit.)
You will have an acupuncture session 3 times per week for 4 weeks (Weeks 1-4). You will then have 1 week off (Week 5). After that, you will have an acupuncture session twice per week for 4 more weeks (Weeks 6-10). This is a total of 20 sessions. In addition to the 20 planned sessions, you may also choose to receive an optional 21st acupuncture session at the end-of-study visit that is scheduled for Week 13.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, or the legal guardians of patients, must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- •Age > 18 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
- •Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 scale in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed. Patients will be removed from the study if a change in type of medication is necessary. All patients will receive treatment to both upper and lower extremities, regardless of whether or not they are experiencing symptoms in all four extremities.)
- •The patient's previous chemotherapy treatment must have included thalidomide and/or bortezomib and/or any derivatives.
- •Eastern Cooperative Oncology Group (ECOG) 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
- •Current active treatment with thalidomide and/or bortezomib.
- •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 infection.)
- •Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
- •Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and anticoagulation agents.
- •Known coagulopathy and taking heparin (including low molecular weight heparin) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories will be allowed to participate.
- •Platelets < 50 H K/UL.
- •White Blood Counts (WBCs) < 3.0 K/UL.
- •Active central nervous system (CNS) disease. (The action for acupuncture may be associated with central nervous system activity, and patients with CNS pathology may respond differently to treatment than the general population.)
- •Cardiac pacemaker.
- •Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
- •Currently pregnant or lactating females. (Certain acupuncture applications have been reported to stimulate uterine contractions and may alter lactation.)
- •Chronic alcohol use as clinically estimated by the patient's physician.
- •History of diabetic neuropathy or neuropathy related to HIV.
- •Previous acupuncture treatment for any indication within 30 days of enrollment.
- •Active treatment for lymphoma, non-Hodgkin's lymphoma or multiple myeloma.
- •Planned or actual changes in type of medications that could affect symptoms related to peripheral neuropathy (PN). Note: Minor adjustments in current medications at the time of enrollment is allowed.
研究组 & 干预措施
Acupuncture
3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
干预措施: Acupuncture (Other)
结局指标
主要结局
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
时间窗: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.
Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).
次要结局
未报告次要终点