Chemotherapy-induced Peripheral Neuropathy (CIPN)NCT03634527
Auricular Point Acupressure: Examining the Scientific Underpinnings of Pain Relief
A study testing Auricular Point Acupressure in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Johns Hopkins University at 1 site in United States.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN)-numbness, burning and stunning pain distributed in hands and feet-is a major challenge among cancer patients. Even after completion of chemotherapy, CIPN persists among ~30-40% of cancer patients, which can negatively impact quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Auricular Point Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients who are 18 years of age or olde
- Able to read and write English
- Have CIPN due to received neurotoxic chemotherapy for cancer
- Had average intensity of pain due to CIPN ≥ 4 on a 11-point numerical pain scale in the previous week
- Pain > 3 months duration attributed to CIPN.
Who cannot join
- Use of an investigational agent for pain control concurrently or within the past 30 days;
- Use of an implantable drug delivery systems, 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, pre-existing peripheral neuropathy of another etiology
- Allergy to latex (the tapes for the APA include latex).
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy-induced peripheral neuropathy (CIPN)-numbness, burning and stunning pain distributed in hands and feet-is a major challenge among cancer patients. Even after completion of chemotherapy, CIPN persists among ~30-40% of cancer patients, which can negatively impact quality of life. The only drug (duloxetine) better than placebo in a randomized control trial improved pain intensity by 0.72 points on a scale of 0-10, which cannot manage CIPN effectively. A better pain management strategy clearly needs to be developed.
The investigators propose to test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and effective pain relief so that cancer patients can self-manage their CIPN. APA involves an acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and index finger, three times a day (morning, noon, and evening) for three minutes each session to achieve pain relief. The investigators have developed a detailed APA protocol to teach health-care providers without experience in acupuncture and traditional Chinese Medicine that investigators can learn about APA in brief educational seminars as a treatment including the systematic identification of ear points (called auricular diagnosis). The investigators teach methods that enable patients to continue using APA to self-manage their pain. However APA is not available in current U.S. health care setting yet.
Read more
Quantitative sensory testing (QST) and fMRI in acupuncture have provided new objective methods for measuring pain. QST provides an evaluation of peripheral and central mechanisms of pain by quantifying stimulus-evoked negative and positive sensory phenomena to evaluate a participant's perception of threshold values regarding pain generated through touch (A beta fibers), warmth (C fibers), cold (A delta fibers), and heat (C fibers). Studies have demonstrated changes in heat, pressure, and mechanical pain thresholds immediately following acupuncture; however no study in APA yet. Brain imaging studies in acupuncture indicate that acupuncture can restore normal functional connectivity related to pain reduction. In conjunction with the investigators pilot data demonstrating that APA impacts neural-immune signaling in patients with chronic low back pain, the investigators hypothesize that APA may likewise induce pain relief through the stimulation of A beta fibers and/or C fibers to increase the pain threshold, endogenous opioid binding (releasing inflammatory cytokines), and alter brain networks of central processing in the hypothalamic-pituitary-adrenocortical axis to achieve analgesia.
The investigators plan to study the mechanisms underpinning pain sensitivity and pain processing due to APA on CIPN. Along with the clinical and subjective CIPN outcomes, objective outcomes will include physiological change in pain sensory thresholds (measured by quantitative sensory testing), brain change associated with pain processing (measured by fMRI), and neuro-transmitters (measured by inflammatory cytokines).
- Being tested
- Auricular Point Acupressure, Control Auricular Point Acupressure-
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Point AcupressureBehavioural
Light touch using vaccaria seeds on specific points of the ear
Control Auricular Point Acupressure-Behavioural
Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
| Study group | Role | What they receive |
|---|---|---|
| Auricular Point Acupressure | Experimental | Auricular points related to Chemotherapy-induced peripheral neuropathy (CINP) will be used for the intervention. Receives: Behavioral: Auricular Point Acupressure |
| Control Auricular Point Acupressure | Sham comparator | Auricular points not related to CINP will be used for the intervention. Receives: Behavioral: Control Auricular Point Acupressure- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity as assessed by the Brief Pain Inventory-short form (BPI-sf) questionnaire
The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.
Measured: Baseline, weekly upto 4 Weeks.
Secondary outcomes (4)
Change in Quantitative Sensory Testing (QST) score
Quantitative Sensory Testing will be measured by cold pressor testing, conditional pain modulation, mechanical pain threshold. The percentage of change score (from each end point to baseline) will be used (0-100) with higher scores indicating less pain
Measured: Baseline, weekly upto 4 weeks
Change in pain response assessed by functional MRI Scan
The baseline rs-fMRI will be performed, followed by 10 min of APA. Immediately after the treatment, a repeat fMRI will then be performed. All MRIs will be acquired on a 3.0 Tesla Siemens Trio Tim system (Siemens Medical Solutions, Erlangen, Germany) using a 12-channel head matrix coil T2*-weighted bold functional images covering entire cerebrum and cerebellum. fMRI will take ~45 minutes. The imaging data will be processed using Statistical Parametric Mapping version 8.
Measured: baseline, post-4weekly APA treatment, and one month followup
Change in functional status as assessed by the e Patient-Reported Outcomes Measurement Information System (PROMIS) 29 scale
PROMIS 29 will be used to assess Anxiety, Depression, Fatigue, and Sleep Disturbance.The PROMIS-29 scale, which includes: Pain Interference - 4 items; Pain Intensity- 1 item; Physical Function - 4 items; Fatigue - 4 items;Depression - 4 items; Anxiety - 4 items; Sleep Disturbance - 4 items; Satisfaction with Social Participation- 4 items
Measured: weekly up to one month post-intervention
Change in Inflammatory Cytokines
It will be measured by blood serum
Measured: baselines, weekly upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start15 Feb 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Funding duration ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Hsing Yeh, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634527
- Sponsor's protocol ID
- IRB00119665
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Have not decided since this is a pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Point Acupressure: Examining the Scientific Underpinnings of Pain Relief
- ClinicalTrials.gov ID
- NCT03634527
- Acronym / sponsor ID
- IRB00119665
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding duration ended.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy-induced peripheral neuropathy (CIPN)-numbness, burning and stunning pain distributed in hands and feet-is a major challenge among cancer patients. Even after completion of chemotherapy, CIPN persists among ~30-40% of cancer patients, which can negatively impact quality of life. The only drug (duloxetine) better than placebo in a randomized control trial improved pain intensity by 0.72 points on a scale of 0-10, which cannot manage CIPN effectively. A better pain management strategy clearly needs to be developed.
The investigators propose to test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and effective pain relief so that cancer patients can self-manage their CIPN. APA involves an acupuncture-like stimulation of the ear without needles. With APA, small seeds are taped to specific ear points. The patient is taught to apply pressure to the seeds, with the thumb and index finger, three times a day (morning, noon, and evening) for three minutes each session to achieve pain relief. The investigators have developed a detailed APA protocol to teach health-care providers without experience in acupuncture and traditional Chinese Medicine that investigators can learn about APA in brief educational seminars as a treatment including the systematic identification of ear points (called auricular diagnosis). The investigators teach methods that enable patients to continue using APA to self-manage their pain. However APA is not available in current U.S. health care setting yet.
Quantitative sensory testing (QST) and fMRI in acupuncture have provided new objective methods for measuring pain. QST provides an evaluation of peripheral and central mechanisms of pain by quantifying stimulus-evoked negative and positive sensory phenomena to evaluate a participant's perception of threshold values regarding pain generated through touch (A beta fibers), warmth (C fibers), cold (A delta fibers), and heat (C fibers). Studies have demonstrated changes in heat, pressure, and mechanical pain thresholds immediately following acupuncture; however no study in APA yet. Brain imaging studies in acupuncture indicate that acupuncture can restore normal functional connectivity related to pain reduction. In conjunction with the investigators pilot data demonstrating that APA impacts neural-immune signaling in patients with chronic low back pain, the investigators hypothesize that APA may likewise induce pain relief through the stimulation of A beta fibers and/or C fibers to increase the pain threshold, endogenous opioid binding (releasing inflammatory cytokines), and alter brain networks of central processing in the hypothalamic-pituitary-adrenocortical axis to achieve analgesia.
The investigators plan to study the mechanisms underpinning pain sensitivity and pain processing due to APA on CIPN. Along with the clinical and subjective CIPN outcomes, objective outcomes will include physiological change in pain sensory thresholds (measured by quantitative sensory testing), brain change associated with pain processing (measured by fMRI), and neuro-transmitters (measured by inflammatory cytokines).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Point Acupressure | Experimental | Behavioral: Auricular Point AcupressureAuricular points related to Chemotherapy-induced peripheral neuropathy (CINP) will be used for the intervention. |
| Control Auricular Point Acupressure | Sham comparator | Behavioral: Control Auricular Point Acupressure-Auricular points not related to CINP will be used for the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cancer patients who are 18 years of age or olde
- Able to read and write English
- Have CIPN due to received neurotoxic chemotherapy for cancer
- Had average intensity of pain due to CIPN ≥ 4 on a 11-point numerical pain scale in the previous week
- Pain > 3 months duration attributed to CIPN.
Key exclusion criteria (5 listed)
- Use of an investigational agent for pain control concurrently or within the past 30 days;
- Use of an implantable drug delivery systems, 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, pre-existing peripheral neuropathy of another etiology
- Allergy to latex (the tapes for the APA include latex).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Point AcupressureLight touch using vaccaria seeds on specific points of the ear | Behavioural | Auricular Point Acupressure |
| Control Auricular Point Acupressure-Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | Behavioural | Control Auricular Point Acupressure |
Primary outcome
Change in Pain intensity as assessed by the Brief Pain Inventory-short form (BPI-sf) questionnaire
Time frame: Baseline, weekly upto 4 Weeks.
The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.
4 secondary outcomes
Change in Quantitative Sensory Testing (QST) score
Time frame: Baseline, weekly upto 4 weeks
Change in pain response assessed by functional MRI Scan
Time frame: baseline, post-4weekly APA treatment, and one month followup
Change in functional status as assessed by the e Patient-Reported Outcomes Measurement Information System (PROMIS) 29 scale
Time frame: weekly up to one month post-intervention
Change in Inflammatory Cytokines
Time frame: baselines, weekly upto 4 weeks
Results and safety
The study was stopped early (reason given: Funding duration ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided. Have not decided since this is a pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Hsing Yeh principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Point Acupressure in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Johns Hopkins University at 1 site 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Funding duration ended.). Results are not available in the source record.
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?
Change in Pain intensity as assessed by the Brief Pain Inventory-short form (BPI-sf) questionnaire (time frame: Baseline, weekly upto 4 Weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2021.