Acupuncture for Chemotherapy-Induced Peripheral Neuropathy Among Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
研究概览
简要总结
The goal of this study is to obtain preliminary evidence of the effect of 8 acupuncture treatments over 10 weeks in breast and GI cancer patients who are currently receiving or recently completed active neurotoxic chemotherapy and have clinically documented grade 1 or 2 neuropathy.
详细描述
PRIMARY OBJECTIVES:
I. To obtain preliminary evidence of the clinical effects of acupuncture compared to usual care on the change in sensory neuropathic pain as measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 item (20) sensory subscale.
SECONDARY OBJECTIVES:
I. Change in the motor and autonomic neuropathic pain subscores on the EORTC QLQ-CIPN20.
II. Change in patient-reported assessment of numbness and tingling using the 2-item Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) measure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast and GI cancer stage I-III
- •Currently receiving or recently completed neurotoxic chemotherapy (either adjuvant or neoadjuvant). Currently is defined as including up until when the next cycle would be delivered, that is if the patient is getting chemotherapy every week, this would include a week after their last treatment; if the patient is getting treatment every 2 weeks, this would include 2 weeks after their last treatment; if the patient is getting treatment every 3 weeks, this would include 3 weeks after their last treatment, etc. Recently completed is defined as 6 weeks after this time period. For example, if a patient was getting chemotherapy every week, this would include seven weeks after their last treatment; if the patient was getting treatment every 2 weeks, this would include 8 weeks after their last treatment; if the patient were getting treatment every 3 weeks, this would include 9 weeks after their last treatment, etc.
- •Clinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the National Cancer Institute (NCI)-CTCAE
- •Ability and willingness to understand and sign an informed consent
排除标准
- •Self-reported or documented history of UNRESOLVED pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions.
- •Unable to provide medical history.
- •Male patients.
- •Pregnant.
- •Unwilling to receive acupuncture or unable to travel for treatments.
结局指标
主要结局
Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
时间窗: Baseline up to week 12
Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
次要结局
- Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20(Baseline up to week 12)
- Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling(Baseline up to week 12)
- CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling(Up to week 12)
- Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy(Up to week 12)
- Number of Cycles of Completed Chemotherapy(Up to week 12)
- Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)(Up to week 12)
- Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)(Up to week 12)
- Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)(Up to week 12)
- Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)(Up to week 12)
- Nerve Fiber Density in the Skin(Up to week 12)