Randomized-Controlled Trial of Acupuncture for Chronic Pain After Breast Cancer Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change in pain scores assessed by Brief Pain Inventory (BPI)
研究概览
简要总结
This randomized phase II trial studies how well electroacupuncture therapy works in reducing chronic pain in patients following surgery for stage I-III breast cancer. Electroacupuncture therapy is a type of complementary integrative medicine in which pulses of weak electrical current are sent through very thin, solid, sterile, stainless steel needles into certain points in the skin. Electroacupuncture therapy may help to lower pain and other surgery-related symptoms.
详细描述
PRIMARY OBJECTIVE:
I. Determine the initial efficacy of electroacupuncture (EA) in reducing chronic pain in women following treatment for breast cancer.
SECONDARY OBJECTIVES:
I. Determine if EA produces greater improvement in physical functional mobility as compared to sham electroacupuncture (SEA) or waitlist control (WLC)s.
II. Determine if EA produces greater improvement in overall quality of life (QOL) and symptoms related to fatigue, sleep and mood disturbance compared to SEA or WLC.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Be adult women >/= 18 years of age.
- •Be able to read, write, and speak English
- •Able to give informed consent
- •Have a history of stage I, II, or III breast cancer
- •Have a documented visit with an oncologist during the previous 12-months
- •Have no current evidence of disease
- •Have persistent pain (unrelated to aromatase inhibitors or chemotherapy-induced peripheral neuropathy) for at least 3 months following treatment for breast cancer
- •Have pain severity (arithmetic mean of four pain severity items) >= 2 on Brief Pain Inventory (BPI)
- •Have worst pain >= to 4 (0-10 numeric rating scale [NRS]) in the preceding week
- •Be willing and able to adhere to all study-related procedures
- •Have completed all cancer treatment (including surgery, chemotherapy and/or radiation) at least 4 months prior to enrollment
- •Have documented lab work with absolute neutrophil count (ANC) >= 1.0 K/uL and platelets >= 50 K/uL in the past 12 months
- •If applicable, maintain self-management of lymphedema symptoms being performed at home at time of study entry
排除标准
- •Metastatic breast cancer (stage IV)
- •Known bleeding disorder per patient reported history
- •Cardiac pacemaker or other implanted electronic devices
- •New or planned new lymphedema treatment during the study period
- •Currently receiving or ever received acupuncture for present pain condition
- •Received acupuncture with electrical stimulation for any condition
- •Received acupuncture for any condition in the past year
研究组 & 干预措施
Group I (electroacupuncture therapy)
Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (electroacupuncture therapy)
Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
干预措施: Quality-of-Life Assessment (Other)
Group I (electroacupuncture therapy)
Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
干预措施: Questionnaire Administration (Other)
Group I (electroacupuncture therapy)
Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
干预措施: Electroacupuncture Therapy (Procedure)
Group II (sham electroacupuncture therapy)
Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.
干预措施: Electroacupuncture Therapy (Procedure)
Group II (sham electroacupuncture therapy)
Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.
干预措施: Laboratory Biomarker Analysis (Other)
Group II (sham electroacupuncture therapy)
Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.
干预措施: Quality-of-Life Assessment (Other)
Group II (sham electroacupuncture therapy)
Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.
干预措施: Questionnaire Administration (Other)
Group III (waitlist control)
Patients receive standard of care without any kind of acupuncture therapy.
干预措施: Laboratory Biomarker Analysis (Other)
Group III (waitlist control)
Patients receive standard of care without any kind of acupuncture therapy.
干预措施: Quality-of-Life Assessment (Other)
Group III (waitlist control)
Patients receive standard of care without any kind of acupuncture therapy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in pain scores assessed by Brief Pain Inventory (BPI)
时间窗: Baseline to 8 weeks
Change in pain scores will be compared between groups. Assessing the initial efficacy of electroacupuncture (EA) relative to sham electroacupuncture (SEA) and waitlist control (WLC), use linear regression and linear mixed model analyses. Pain Scores(0-10) 0 No pain-10 Worst Pain.
次要结局
- Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase(Up to 8 weeks)
- Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis(Baseline to 8 weeks)
- Caregiver Reaction Assessment (CRA) Questionnaire(Up to 8 weeks)
- Changes in symptoms of fatigue questionnaire(Baseline to 8 weeks)
- Changes in symptoms of sleep questionnaire(Baseline to 8 weeks)
- Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1(Up to 8 weeks)
- Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire(Up to 8 weeks)
- Baseline expectancy of participants will be correlated to the outcomes response.(At baseline)
- Physical functional mobility will be compared.(Baseline to 8 weeks)
- Quality of life (QOL) questionnaire(Baseline to 8 weeks)
- Changes in symptoms of mood disturbance(Baseline to 8 weeks)