A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Change in the Neuropathic Pain Symptom Inventory Scores
研究概览
简要总结
RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.
详细描述
PRIMARY OBJECTIVE:
I. To explore the potential for the use of acupuncture to prevent a worsening of the nerve damage in patients (during treatment) due to paclitaxel as measured by a Neuropathic Pain Symptom Inventory.
SECONDARY OBJECTIVES:
I. Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory tests and nerve conduction tests.
II. Evaluate the improvement observed when treating patients for peripheral neuropathy (post-chemotherapy) with acupuncture based on the same metrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
- •Performance ECOG 0-2 (Karnofsky Performance Status >= 60%)
- •Life expectancy of greater than 6 months
- •Ability to understand and the willingness to sign a written informed consent document
- •Patients with radiologically confirmed stage IV breast cancer
- •Patients who had acupuncture in the previous 8 weeks
- •Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
- •Patients with needle phobia
- •Patients who experienced any peripheral neuropathy prior to chemotherapy
- •Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
- •Patients with diabetes
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
干预措施: acupuncture therapy (Other)
Arm I
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
干预措施: questionnaire administration (Other)
Arm I
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
干预措施: management of therapy complications (Other)
Arm II
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
干预措施: acupuncture therapy (Other)
Arm II
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
干预措施: questionnaire administration (Other)
Arm II
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
干预措施: management of therapy complications (Other)
结局指标
主要结局
Change in the Neuropathic Pain Symptom Inventory Scores
时间窗: At the end of 4 courses of chemotherapy
次要结局
- Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management(Eight weeks after study enrollment)
- Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment(Eight weeks after study enrollment)
- Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture(Eight weeks after study enrollment)
- Comparison of changes in neurological assessment of patients(At the end of therapy and 1 month after the end of therapy)
- Correlation between nerve inventory questionnaires and quantitative nerve tests(Eight weeks after study enrollment)