AzTrials
AzTrials

Chemotherapy-induced NeuropathyNCT04920097

Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

A study testing In-person training for seed placement and APA, Virtual training for seed placement and APA and Post-training zoom session for seed placement and APA coaching in people with Chemotherapy-induced Neuropathy, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chemotherapy-induced Neuropathy
What is being tested?
In-person training for seed placement and APA, Virtual training for seed placement and APA and Post-training zoom session for seed placement and APA coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
2 sitesUnited States
Study dates
8 Jul 2021to 19 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

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).

Read the detailed description

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.

Being tested
In-person training for seed placement and APA, Virtual training for seed placement and APA, Usual Care, Post-training zoom session for seed placement and APA coaching
Keywords
acupressure, chemotherapy induced neuropathy, auricular acupressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-person training for seed placement and APAOther

    In-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points.

  • Virtual training for seed placement and APAOther

    Also called Self-guided smartphone app with video instruction for seed placement and APA

    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.

  • Usual CareOther

    Participants will continue with usual care from oncologist.

  • Post-training zoom session for seed placement and APA coachingOther

    Zoom session for seed placement and APA coaching, to occur after initial APA and seed placement training (initial training is either in person or guided by the smartphone app videos).

Study groups in NCT04920097
Study groupRoleWhat they receive
Auricular Point Acupressure (APA)ExperimentalThe 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.
Receives: Other: In-person training for seed placement and APA; Other: Post-training zoom session for seed placement and APA coaching
Virtual Auricular Point Acupressure (vAPA)ExperimentalThe 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.
Receives: Other: Virtual training for seed placement and APA; Other: Post-training zoom session for seed placement and APA coaching
Usual Care ControlActive comparatorUsual Care arm will continue with their usual care.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Severity as Assessed by the Brief Pain Inventory

    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

    Measured: Baseline, 1 month after baseline

  2. Numbness as Assessed by the Brief Pain Inventory

    Brief Pain Inventory (BPI) assesses worst numbness. The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.

    Measured: Baseline, 1 month after Baseline

  3. Tingling as Assessed by the Brief Pain Inventory

    Brief Pain Inventory (BPI) assesses worst Tingling. The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.

    Measured: Baseline, 1 month after baseline

  4. Stiffness as Assessed by the Brief Pain Inventory

    Brief Pain Inventory (BPI) assesses worst stiffness. The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.

    Measured: Baseline, 1 month after baseline

  5. Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4

    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.

    Measured: Baseline, 1 month after baseline

  6. Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4

    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.

    Measured: Baseline, 1 month after baseline

  7. Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale

    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.

    Measured: Baseline, 1 month after Baseline

  8. Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

    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

    Measured: Baseline, 1 month after Baseline

  9. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale

    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.

    Measured: Baseline, 1 month after baseline

  10. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale

    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.

    Measured: Baseline, 1 month after baseline

  11. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale

    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.

    Measured: Baseline, 1 month after baseline

  12. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale

    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.

    Measured: Baseline, 1 month after baseline

  13. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale

    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.

    Measured: Baseline, 1 month after baseline

  14. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale

    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.

    Measured: Baseline, 1 month after baseline

  15. Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale

    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.

    Measured: Baseline, 1 month after baseline

  16. Upper Limb Function as Assessed by the Quick Dash Index

    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.

    Measured: Baseline, 1 month after baseline

  17. Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory

    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.

    Measured: Baseline, 1 month after Baseline

  18. Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)

    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.

    Measured: Baseline, 1 month after Baseline

  19. Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score

    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.

    Measured: Baseline, 1 month after Baseline

  20. Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)

    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.

    Measured: Baseline, 1 month after Baseline

  21. Charlson Comorbidity Index

    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.

    Measured: Baseline

  22. Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale

    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.

    Measured: Baseline, 1 month after baseline

  23. Number of Participants Reporting Opioid Use

    Measured: Baseline, Day 28

  24. Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day

    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.

    Measured: Baseline, Day 28

Secondary outcomes (28)

  1. Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.

    Measured: Baseline, 1 month after Baseline

  2. Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.

    Measured: Baseline, 1 month after Baseline

  3. Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation. Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. A higher score means greater pain sensitivity and increased temporal summation. MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series.

    Measured: Baseline, 1 month after Baseline

  4. Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)

    In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM). CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds. [ [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]

    Measured: Baseline, 1 month after Baseline

  5. Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging

    Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline). Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions. Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.

    Measured: Baseline

  6. Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging

    Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline). Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions. Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.

    Measured: Baseline, 1 month after Baseline

  7. The Grooved Pegboard Test-Dominant Hand

    The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination. Participants are asked to place 25 pegs into slots as quickly as possible. The total time to complete the task is recorded in seconds with dominant hand. Higher times indicate slower performance and reduced dexterity

    Measured: Baseline, 1 month after baseline

  8. The Grooved Pegboard Test-Non Dominant Hand

    The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination. Participants are asked to place 25 pegs into slots as quickly as possible. The total time to complete the task is recorded in seconds with non-dominant hand. Higher times indicate slower performance and reduced dexterity

    Measured: Baseline, 1 month after Baseline

  9. Interleukin-1 Alpha Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  10. Interleukin-1 Beta Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  11. Interleukin-2 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  12. Interleukin-4 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  13. Interleukin-6 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  14. Interleukin-8 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  15. Interleukin-10 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  16. Interleukin-12 Level (p40) (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  17. Interleukin-12 Level (p70)-(From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  18. Interleukin-13 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  19. Interleukin-17 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  20. Interferon-gamma Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after Baseline

  21. Tumor Necrosis Factor-alpha Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline

  22. Tumor Necrosis Factor-alpha Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: 1 month after baseline

  23. Transforming Growth Factor-beta Level 1(From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline

  24. Transforming Growth Factor-beta Level 1 (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: 1 month after baseline

  25. Calcitonin Gene-related Peptide Level(From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after baseline

  26. Monocyte Chemoattractant Protein-1 Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after baseline

  27. Eotaxin Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after baseline

  28. C-reactive Protein Level (From Plasma)

    Blood samples were collected to measure cytokines and inflammatory biomarkers. Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay. Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.

    Measured: Baseline, 1 month after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start8 Jul 2021
  3. Primary completion30 May 2025
  4. Study completion19 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920097
Sponsor's protocol ID
HSC-SN-21-1085
Other IDs
1R01CA245054-01A1
Status last verified
Jul 2026
First submitted
3 Jun 2021
Last updated
4 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah A, Hoffman EM, Mauermann ML, Loprinzi CL, Windebank AJ, Klein CJ, Staff NP. Incidence and disease burden of chemotherapy-induced peripheral neuropathy in a population-based cohort. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):636-641. doi: 10.1136/jnnp-2017-317215. Epub 2018 Feb 8.

    PubMed 29439162

  • Park SB. Chemotherapy-induced peripheral neuropathy: highlighting unmet needs. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):558. doi: 10.1136/jnnp-2017-317528. Epub 2018 Feb 20. No abstract available.

    PubMed 29463571

  • Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.

    PubMed 28486769

  • Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

    PubMed 25261162

  • Miaskowski C, Mastick J, Paul SM, Abrams G, Cheung S, Sabes JH, Kober KM, Schumacher M, Conley YP, Topp K, Smoot B, Mausisa G, Mazor M, Wallhagen M, Levine JD. Impact of chemotherapy-induced neurotoxicities on adult cancer survivors' symptom burden and quality of life. J Cancer Surviv. 2018 Apr;12(2):234-245. doi: 10.1007/s11764-017-0662-8. Epub 2017 Nov 20.

    PubMed 29159795

  • Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.

    PubMed 24733808

  • Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.

    PubMed 23549581

  • Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, Fung C, Janelsins MC, Asare M, Lin PJ, Reddy PS, Giguere J, Berenberg J, Kesler SR, Mustian KM. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1019-1028. doi: 10.1007/s00520-017-4013-0. Epub 2017 Dec 14.

    PubMed 29243164

  • Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005 Mar 31;352(13):1324-34. doi: 10.1056/NEJMoa042580.

    PubMed 15800228

  • Gilron I, Tu D, Holden RR, Jackson AC, DuMerton-Shore D. Combination of morphine with nortriptyline for neuropathic pain. Pain. 2015 Aug;156(8):1440-1448. doi: 10.1097/j.pain.0000000000000149.

    PubMed 25749306

  • Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.

    PubMed 26977696

  • Yeh CH, Lukkahatai N, Campbell C, Sair H, Zhang F, Mensah S, Garry C, Zeng J, Chen C, Pinedo M, Khoshnoodi M, Smith TJ, Saligan LN. Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 1 Self-Reported Outcomes. Pain Manag Nurs. 2019 Dec;20(6):614-622. doi: 10.1016/j.pmn.2019.04.005. Epub 2019 May 30.

    PubMed 31155279

  • Yeh CH, Lin WC, Kwai-Ping Suen L, Park NJ, Wood LJ, van Londen GJ, Howard Bovbjerg D. Auricular Point Acupressure to Manage Aromatase Inhibitor-Induced Arthralgia in Postmenopausal Breast Cancer Survivors: A Pilot Study. Oncol Nurs Forum. 2017 Jul 1;44(4):476-487. doi: 10.1188/17.ONF.476-487.

    PubMed 28632237

  • Yeh CH, Kwai-Ping Suen L, Chien LC, Margolis L, Liang Z, Glick RM, Morone NE. Day-to-Day Changes of Auricular Point Acupressure to Manage Chronic Low Back Pain: A 29-day Randomized Controlled Study. Pain Med. 2015 Oct;16(10):1857-69. doi: 10.1111/pme.12789. Epub 2015 May 19.

    PubMed 25988270

  • Yeh CH, Morone NE, Chien LC, Cao Y, Lu H, Shen J, Margolis L, Bhatnagar S, Hoffman S, Liang Z, Glick RM, Suen LK. Auricular point acupressure to manage chronic low back pain in older adults: a randomized controlled pilot study. Evid Based Complement Alternat Med. 2014;2014:375173. doi: 10.1155/2014/375173. Epub 2014 Jul 24.

    PubMed 25147574

Questions about this trial

What is this clinical trial studying?

A study testing In-person training for seed placement and APA, Virtual training for seed placement and APA and Post-training zoom session for seed placement and APA coaching in people with Chemotherapy-induced Neuropathy, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Severity as Assessed by the Brief Pain Inventory (time frame: Baseline, 1 month after baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920097, which also lists 90 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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