Peripheral NeuropathyNCT03881748
Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
A study testing Manual acupuncture and Electro-acupuncture in people with Peripheral Neuropathy, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve chemo-therapy induced neuropathy in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Manual acupuncture and Electro-acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2021to Dec 2021
- 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
- Participants must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- History of a diagnosis of cancer, verifiable through documentation in a medical record.
- Participants must have neuropathy ≥1 according to CTCAE v 4.0 scale or a neuropathy score of >3 on a 0-10 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica.
- The participant's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team.
- More than 6 months since last treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Willingness to comply with all study interventions of acupuncture and follow-up assessments.
Who cannot join
- Current active treatment with chemotherapy, radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
- Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy within the past 6 months.
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, participants will be excluded if there is an indication of infection.)
- Physical deformities that could interfere with accurate acupuncture point location.
- Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals.
- Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Participants on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate.
Show all 16Show fewer
- Platelets < 50 H K/UL in the past 30 days.
- White Blood Cells (WBCs) < 3.0 K/UL or absolute neutrophil count (ANC) <1,500 K/UL) in the past 30 days.
- Active Central Nervous System (CNS) disease. (The action for acupuncture may be associated with central nervous system activity, and participants with CNS pathology may respond differently to treatment than the general population.)
- Implanted electrical device such as cardiac pacemaker, insulin pump, or pain pump.
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These participants may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
- Currently pregnant. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
- History of diabetic neuropathy, neuropathy related to HIV, or other medical causes of chronic neuropathy in the baseline assessment including past medical history, any history of diabetes, alcoholism, and vitamin B.
- Previous acupuncture treatment for any indication within 30 days of enrollment.
- Planned or actual changes in type of medications that could affect symptoms related to chemotherapy-induced peripheral neuropathy (CIPN). New medications for the treatment of CIPN are not allowed during the study. Subjects need to be on stable doses of CIPN medications for 4 weeks.
- Grade III lymphedema or lymphedema considered severe by the treating clinician
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Randomized Phase II Pilot Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve chemo-therapy induced neuropathy in cancer patients. If eligible to take part in this study, participants will be randomly assigned to 1 of 2 groups - group 1 participants will receive traditional acupuncture treatments 2 times a week for a total of 20 sessions. Group 2 participants will have acupuncture sessions with electrical stimulation 2 times a week for a total of 20 sessions.
Read the detailed description
Peripheral neuropathy is a common problem among cancer patients who have received chemotherapy treatment. Peripheral neuropathy often causes weakness, numbness and pain, usually in the hands and feet. It can also affect other areas of the body. People with peripheral neuropathy generally describe the pain as stabbing, burning or tingling.
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Research has shown that acupuncture can reduce symptoms of pain and nausea by altering pain signaling along nerves. The effect of acupuncture can be enhanced by additional movement of the needles called manual acupuncture, which involves rotating the needle and moving it up and down. Another type of acupuncture is called electro-acupuncture, which involves running a low level electrical current between two needle points. Preliminary studies indicate that acupuncture may also be helpful to treat chemotherapy related neuropathy. This trial will determine the relative effects of both manual acupuncture and electro-acupuncture for treating chronic chemotherapy-induced neuropathy.
Participants will be assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.
- Conditions
- Peripheral Neuropathy
- Being tested
- Manual acupuncture, Electro-acupuncture
- Keywords
- Acupuncture
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupunctureOther
Manual acupuncture twice a week for 20 treatments.
Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.
Electro-acupunctureOther
Electro-acupuncture twice a week for 20 treatments.
Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.
Electrical stimulation will be applied to the needles concomitantly and continuously to acupuncture points by placing lead wires on the needles connected to an electro-acupuncture stimulator such as the Model IC-1107. The stimulator will be set on the Dense-Disperse wave setting with low frequency at 2-10 Hz and high frequency at 100-110 Hz. The needles will not be manually stimulated after electrical stimulation is applied.
| Study group | Role | What they receive |
|---|---|---|
| Manual acupuncture | Experimental | Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points. Receives: Other: Manual acupuncture |
| Electro-acupuncture | Experimental | Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points with additional application of weak electrical stimulation Receives: Other: Electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion rate
Percent of participants that complete the treatment protocol, with completions being defined as receiving at least 20 acupuncture treatments within 2 weeks of the scheduled course of treatments (Which is 12 weeks).
Measured: Up to 12 weeks from start of study.
Secondary outcomes (9)
Cancer-specific, health-related quality of life as measured by FACT-G
Cancer-specific, health-related quality of life as measured by Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire. The range of scores lies on a spectrum of 0 - 108, with higher scores indicating better quality of life.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Peripheral neuropathy or neuropathy as measured by (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-Ntx)
The Ntx subscale is an 11-item questionnaire to assess neurotoxic effects of chemotherapy with scores ranging on a scale of 11-44.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Quality of life as measured by Total Neuropathy Score - Clinically Based (TNSc)
The Total Neuropathy Score - Clinically Based (TNSc) scale is a 10-item scale assessing chemotherapy-induced peripheral neuropathy with scores ranging on a scale of 0-44. Higher scores indicate worse symptoms.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Quality of life as measured by Neuropathy Pain Scale (NPS)
The Neuropathy Pain Scale (NPS) is a 10-item scale assessing neuropathic pain with scores ranging on a scale of 0-100. Higher scores indicate worse symptoms.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in participant's ability to detect thermal sensory stimuli as measured by Quantitative Sensory Testing (QST)
Threshold detection of thermal sensory stimuli as measured by Quantitative Sensory Testing (QST) to assess change in participant's ability to detect thermal sensory stimuli.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in participant's ability to detect vibration sensory stimuli as measured by Quantitative Sensory Testing (QST)
Threshold detection of vibration sensory stimuli as measured by Quantitative Sensory Testing (QST) to assess change in participant's ability to detect vibration sensory stimuli.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in hand function as measured by Grooved Pegboard Test (GPT)
Times the ability of subjects to complete insertion of 25 shaped pegs and is a surrogate for hand function. Subjects will be asked to complete the GPT twice and the time will be averaged for each assessment time point. An increasing time to complete the task would indicate worsening hand function due to neuropathy symptoms. Change in time taken to complete task will be reported.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in balance as measured by Unipedal Stance balance test
Participants will perform a unipedal stance with eyes open for a goal of 45 seconds and will be allowed a total of 3 trials to achieve the 45 seconds with the highest time recorded. A decreasing time of unipedal stance would indicate worsening balance due to neuropathy symptoms. Change in time will be reported.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Use of neuropathic and pain medications
Change in number of medications after treatment (decrease in medications being positive change). These medications may include NSAIDS, acetaminophen, opioid medications (e.g., morphine, oxycodone), amitriptyline, neurontin, pregabalin, carbamezapine, or other related medications.
Measured: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startOct 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lee, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881748
- Sponsor's protocol ID
- CASE4Y18
- Status last verified
- Nov 2021
- First submitted
- 18 Mar 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Pilot Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03881748
- Acronym / sponsor ID
- CASE4Y18
- Conditions
- Peripheral Neuropathy
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Mar 2019 (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.
The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve chemo-therapy induced neuropathy in cancer patients. If eligible to take part in this study, participants will be randomly assigned to 1 of 2 groups - group 1 participants will receive traditional acupuncture treatments 2 times a week for a total of 20 sessions. Group 2 participants will have acupuncture sessions with electrical stimulation 2 times a week for a total of 20 sessions.
Detailed description
Peripheral neuropathy is a common problem among cancer patients who have received chemotherapy treatment. Peripheral neuropathy often causes weakness, numbness and pain, usually in the hands and feet. It can also affect other areas of the body. People with peripheral neuropathy generally describe the pain as stabbing, burning or tingling.
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Research has shown that acupuncture can reduce symptoms of pain and nausea by altering pain signaling along nerves. The effect of acupuncture can be enhanced by additional movement of the needles called manual acupuncture, which involves rotating the needle and moving it up and down. Another type of acupuncture is called electro-acupuncture, which involves running a low level electrical current between two needle points. Preliminary studies indicate that acupuncture may also be helpful to treat chemotherapy related neuropathy. This trial will determine the relative effects of both manual acupuncture and electro-acupuncture for treating chronic chemotherapy-induced neuropathy.
Participants will be assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.
| Arm | Type | Receives |
|---|---|---|
| Manual acupuncture | Experimental | Other: Manual acupunctureInsertion of very thin, solid, sterile, stainless steel needles into the skin at specific points. |
| Electro-acupuncture | Experimental | Other: Electro-acupunctureInsertion of very thin, solid, sterile, stainless steel needles into the skin at specific points with additional application of weak electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- History of a diagnosis of cancer, verifiable through documentation in a medical record.
- Participants must have neuropathy ≥1 according to CTCAE v 4.0 scale or a neuropathy score of >3 on a 0-10 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica.
- The participant's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team.
- More than 6 months since last treatment
Key exclusion criteria (16 listed)
- Current active treatment with chemotherapy, radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
- Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy within the past 6 months.
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, participants will be excluded if there is an indication of infection.)
- Physical deformities that could interfere with accurate acupuncture point location.
- Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals.
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 |
|---|---|---|
| Manual acupunctureManual acupuncture twice a week for 20 treatments. Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes. | Other | Manual acupuncture |
| Electro-acupunctureElectro-acupuncture twice a week for 20 treatments. Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes. Electrical stimulation will be applied to the needles concomitantly and continuously to acupuncture points by placing lead wires on the needles connected to an electro-acupuncture stimulator such as the Model IC-1107. The stimulator will be set on the Dense-Disperse wave setting with low frequency at 2-10 Hz and high frequency at 100-110 Hz. The needles will not be manually stimulated after electrical stimulation is applied. | Other | Electro-acupuncture |
Primary outcome
Treatment completion rate
Time frame: Up to 12 weeks from start of study.
Percent of participants that complete the treatment protocol, with completions being defined as receiving at least 20 acupuncture treatments within 2 weeks of the scheduled course of treatments (Which is 12 weeks).
9 secondary outcomes
Cancer-specific, health-related quality of life as measured by FACT-G
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Peripheral neuropathy or neuropathy as measured by (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-Ntx)
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Quality of life as measured by Total Neuropathy Score - Clinically Based (TNSc)
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Quality of life as measured by Neuropathy Pain Scale (NPS)
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in participant's ability to detect thermal sensory stimuli as measured by Quantitative Sensory Testing (QST)
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in participant's ability to detect vibration sensory stimuli as measured by Quantitative Sensory Testing (QST)
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in hand function as measured by Grooved Pegboard Test (GPT)
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Change in balance as measured by Unipedal Stance balance test
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Use of neuropathic and pain medications
Time frame: At 2, 4, 6, 8, 10, and 14 weeks after start of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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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.
Richard Lee, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture and Electro-acupuncture in people with Peripheral Neuropathy, run by Case Comprehensive Cancer Center 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 7 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Dec 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Treatment completion rate (time frame: Up to 12 weeks from start of study.). 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 1 Dec 2021.