A Phase I-II Study of Acupuncture for the Treatment of Chronic, Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Efficacy of Acupuncture With or Without Electrical Stimulation
研究概览
简要总结
The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve neuropathy in cancer patients.
详细描述
Peripheral neuropathy is a common problem among cancer patients who have received chemotherapy treatment. Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If you are in Group 1, you will have will have acupuncture sessions with electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, you will take a 2 week break. After that, you will randomly assigned to receive 12 sessions of acupuncture with electrical stimulation as before or not have anymore sessions in this study.
- If you are in Group 2, you will have will have acupuncture sessions without electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, you will take a 2 week break. After that, you will randomly assigned to receive 12 extra sessions of acupuncture without electrical stimulation or not have anymore sessions in this study.
- If you are in Group 3, you will have acupuncture sessions 3 times per week over 4 weeks for a total of 12 sessions. You may or may not have electrical stimulation at these sessions. These sessions will begin 14 weeks after you enroll.
Study Visits Before the First Acupuncture Session:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 must have the ability to understand English, Mandarin, or Taiwanese.
- •Sign a written informed consent document.
- •Willing to follow protocol requirements.
- •Age 18 and older.
- •History of diagnosis of cancer.
- •Patients must have neuropathy greater or equal to 2 according to CTCAE v 4.0 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed. Patients will be removed from the study if a change in type of medication is necessary. Patients are allowed to stop medications but not replace them with other medications
- •The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team.
- •ECOG Performance Status of 0, 1, or 2 (Appendix B).
- •Willingness to comply with all study interventions of acupuncture and follow-up assessments.
排除标准
- •Current active treatment with chemotherapy, radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
- •Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
- •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.)
- •Physical deformities that could interfere with accurate acupuncture point location.
- •Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals.
- •Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate.
- •Platelets < 50 H K/UL in the past 30 days.
- •WBCs < 3.0 K/UL or ANC <1,500 K/UL) in the past 30 days.
- •Active 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. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
- •History of diabetic neuropathy or neuropathy related to HIV.
- •Previous acupuncture treatment for any indication within 30 days of enrollment.
- •Planned or actual changes in type of medications that could affect symptoms related to PN. New medications for the treatment of CIPN are not allowed during the study. Note: Subjects need to be on stable doses of CIPN medications for 4 weeks.
- •Grade III lymphedema or lymphedema considered severe by the treating clinician.
结局指标
主要结局
Efficacy of Acupuncture With or Without Electrical Stimulation
时间窗: After 24 acupuncture treatments
Difference in scores compared from baseline to 24 treatments between the two groups with or without electrical stimulations using two-sample t-test. Difference between baseline and 24 treatments assessed in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) subscale scores separately for each of the 2 acupuncture schedules using a paired t test.
Difference in Acupuncture Response
时间窗: After 12 and 24 acupuncture treatments
Effect of 12 versus 24 acupuncture treatments examined for symptoms of chronic, chemotherapy-induced peripheral neuropathy in cancer patients and survivors. Efficacy analysis estimated using average difference between 12-week assessment and 24-week assessment in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)-Neurotoxicity (Ntx) scale for each acupuncture schedule using a paired t test. Response difference examined between 12 versus 24 acupuncture treatments using analysis of variance including the two treatment schedules and the indicator of receiving electrical stimulation as the factors, and considering the interaction between the two factors.
次要结局
- Comparison of Symptom Scores(14 weeks after randomization)