Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Pain Severity as Assessed by the Brief Pain Inventory
研究概览
简要总结
The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (QST), endogenous biomarkers (cytokines), and neuro-imaging to investigate APA's efficacy and underlying mechanism(s).
详细描述
Chemotherapy-induced neuropathy (CIN)-pain, numbness, or tingling distributed in the hands and feet-produces persistent symptoms affecting sensation and balance in cancer survivors. Up to 50% of cancer survivors still suffer CIN 6 years after treatment. Duloxetine, the only recommended drug by the American Society of Clinical Oncology, was found to be superior to placebo but improved CIN by only 0.73 points (0-10 scale). No effective treatment for CIN has been established except exercise, with an effect size of <0.508. Opioids relieve CIN pain, but long-term use is strongly discouraged due to opioid overuse.
The investigators propose to test auricular point acupressure (APA), an innovative and scalable solution developed from auricular acupuncture. APA is a non-invasive (needleless) and active treatment for patients with pain, whereas acupuncture is an invasive (using needles) and passive treatment (administered by a licensed practitioner). In APA, small seeds are taped on specific ear points by a skilled provider and patients press on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and sustains pain relief for one month after a 4-week APA intervention. APA is popular in Taiwan, China, and Europe. Though its use is sparse in the U.S., a limited number of clinical trials have supported APA in pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and interventionists cannot be masked to the three arms. The PI and Co-Is will be blinded regarding arm assignment and will not contact or interact with the participants during the intervention and outcome assessments. Data collector for outcome assessments will be blinded since there will be no seeds placed on the ears when the data are collected.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cancer patients ages ≥18 years
- •have received a medication in one of the following categories: platinum-based, vinca alkaloids, bortezomib, eribulin, and/or taxanes
- •have CIN due to receiving neurotoxic chemotherapy for cancer or have pre-existing peripheral neuropathy of another etiology that worsened after chemotherapy
- •have one of the average intensity of pain, or numbness, or tingling on their extremities the previous week due to CIN ≥ 4 on a 11-point numerical scale.
排除标准
- •use of an investigational agent for pain control concurrently or within the past 30 days
- •use of an implantable drug delivery system, e.g. Medtronic SynchroMed®
- •prior celiac plexus block or other neurolytic pain control treatment
- •other identified causes of painful paresthesia existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy,)
- •allergy to latex (the tapes for the APA include latex) and/or having a history of allergic reactions to the adhesive tape
- •pregnant women (based on the self-reported data)
- •individuals diagnosed with diabetic neuropathy
研究组 & 干预措施
Virtual Auricular Point Acupressure (vAPA)
The vAPA arm will self-administer APA by placing the seeds according to the video instruction found in the self-guided smartphone application for understanding and administering APA. Participant and/or a caregiver will follow the video instruction on seed placement and will receive one zoom session for APA coaching one week after the baseline visit.
干预措施: Virtual training for seed placement and APA (Other)
Virtual Auricular Point Acupressure (vAPA)
The vAPA arm will self-administer APA by placing the seeds according to the video instruction found in the self-guided smartphone application for understanding and administering APA. Participant and/or a caregiver will follow the video instruction on seed placement and will receive one zoom session for APA coaching one week after the baseline visit.
干预措施: Post-training zoom session for seed placement and APA coaching (Other)
Auricular Point Acupressure (APA)
The APA arm will receive in-person weekly treatments and a self-guided smartphone application with videos for understanding and administering APA. The APA arm will receive one in-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points, as well as one zoom meeting 1 week after the first visit to coach participant and/or caregiver on seed placement.
干预措施: In-person training for seed placement and APA (Other)
Auricular Point Acupressure (APA)
The APA arm will receive in-person weekly treatments and a self-guided smartphone application with videos for understanding and administering APA. The APA arm will receive one in-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points, as well as one zoom meeting 1 week after the first visit to coach participant and/or caregiver on seed placement.
干预措施: Post-training zoom session for seed placement and APA coaching (Other)
Usual Care Control
Usual Care arm will continue with their usual care.
干预措施: Usual Care (Other)
结局指标
主要结局
Pain Severity as Assessed by the Brief Pain Inventory
时间窗: Baseline, 1 month after baseline
Brief Pain Inventory (BPI) assesses worst pain severity. The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain
Numbness as Assessed by the Brief Pain Inventory
时间窗: Baseline, 1 month after Baseline
Brief Pain Inventory (BPI) assesses worst numbness. The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.
Tingling as Assessed by the Brief Pain Inventory
时间窗: Baseline, 1 month after baseline
Brief Pain Inventory (BPI) assesses worst Tingling. The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.
Stiffness as Assessed by the Brief Pain Inventory
时间窗: Baseline, 1 month after baseline
Brief Pain Inventory (BPI) assesses worst stiffness. The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.
Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
时间窗: Baseline, 1 month after baseline
Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
时间窗: Baseline, 1 month after baseline
Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale
时间窗: Baseline, 1 month after Baseline
The BPI-CIN Interference subscale will be used to measure physical function caused by CIN. The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life. Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes). The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference.
Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
时间窗: Baseline, 1 month after Baseline
The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction 1. \- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. \- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. \- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. \- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. \- Dead
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate better physical function.
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater fatigue.
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater pain interference.
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater depression severity.
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater anxiety.
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate greater sleep disturbance.
Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale
时间窗: Baseline, 1 month after baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty). Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80. The higher T-scores indicate better and higher functioning social participation.
Upper Limb Function as Assessed by the Quick Dash Index
时间窗: Baseline, 1 month after baseline
The QuickDASH Index assesses upper limb disability and symptoms. It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances. The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability.
Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory
时间窗: Baseline, 1 month after Baseline
The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer. Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine). The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity.
Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)
时间窗: Baseline, 1 month after Baseline
Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ). This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain. Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping.
Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score
时间窗: Baseline, 1 month after Baseline
The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)
时间窗: Baseline, 1 month after Baseline
Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS). This instrument identifies the presence of up to 10 common chronic pain conditions. The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity.
Charlson Comorbidity Index
时间窗: Baseline
The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality. The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality.
Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale
时间窗: Baseline, 1 month after baseline
Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life. Each item is rated on a 0-10 scale. The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference.
Number of Participants Reporting Opioid Use
时间窗: Baseline, Day 28
Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day
时间窗: Baseline, Day 28
Opioid use will be collected via EMA diary using a questionnaire. Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid. Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis. Baseline was defined as the first day of opioid use recorded in the EMA diary.
次要结局
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb(Baseline, 1 month after Baseline)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius(Baseline, 1 month after Baseline)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)(Baseline, 1 month after Baseline)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)(Baseline, 1 month after Baseline)
- Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging(Baseline)
- Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging(Baseline, 1 month after Baseline)
- The Grooved Pegboard Test-Dominant Hand(Baseline, 1 month after baseline)
- The Grooved Pegboard Test-Non Dominant Hand(Baseline, 1 month after Baseline)
- Interleukin-1 Alpha Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-1 Beta Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-2 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-4 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-6 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-8 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-10 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-12 Level (p40) (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-12 Level (p70)-(From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-13 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interleukin-17 Level (From Plasma)(Baseline, 1 month after Baseline)
- Interferon-gamma Level (From Plasma)(Baseline, 1 month after Baseline)
- Tumor Necrosis Factor-alpha Level (From Plasma)(Baseline)
- Tumor Necrosis Factor-alpha Level (From Plasma)(1 month after baseline)
- Transforming Growth Factor-beta Level 1(From Plasma)(Baseline)
- Transforming Growth Factor-beta Level 1 (From Plasma)(1 month after baseline)
- Calcitonin Gene-related Peptide Level(From Plasma)(Baseline, 1 month after baseline)
- Monocyte Chemoattractant Protein-1 Level (From Plasma)(Baseline, 1 month after baseline)
- Eotaxin Level (From Plasma)(Baseline, 1 month after baseline)
- C-reactive Protein Level (From Plasma)(Baseline, 1 month after baseline)
研究者
Jennifer Kawi
Professor
The University of Texas Health Science Center, Houston