Chemotherapy-induced Peripheral NeuropathyNCT07455409
Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
A study testing Electro-acupuncture in people with Chemotherapy-induced Peripheral Neuropathy, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN). The Investigators hypothesize that EA will be a feasible and effective therapy for CIPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Electro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 18 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years
- Received curative-intent chemotherapy (i.e., paclitaxel, docetaxel, nab-paclitaxel, carboplatin, oxaliplatin, vinorelbine, ixabepilone, or vincristine) ≥3 months prior to the start of EA treatment
- Persistent Grade ≥2 peripheral neuropathy in the fingers or toes according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
- Eastern Cooperative Oncology Group performance status of ≤2 (see Section 13.3)
- Willing and able to provide written informed consent for the study.
Who cannot join
- Documented medical history of neuropathy resulting from nerve compression (e.g., carpal tunnel syndrome, radiculopathy, or spinal stenosis)
- Severe coagulopathy or bleeding disorder, per the treating physician's discretion
- Presence of cellulitis or other skin infection or condition that would preclude placement of acupuncture needles into the hands or feet
- Diabetes unless Hgb A1c <7.5%
- Unstable cardiac disease
- Pacemaker
Show all 9Show fewer
- Metal plates
- Known psychiatric disorder that would interfere with cooperation with the requirements of the study
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Neal Cancer Center
Houston, Texas, 77030
About this study
Official title: A Single-Arm Pilot Study of the Feasibility and Efficacy of Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN). The Investigators hypothesize that EA will be a feasible and effective therapy for CIPN.
Read the detailed description
This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
- Being tested
- Electro-acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupunctureDevice
Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
| Study group | Role | What they receive |
|---|---|---|
| Electro-Acupuncture (EA) | Experimental | EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes. Receives: Device: Electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
Measured: 5 Months
Secondary outcomes (2)
Change in Neuropathic Pain After a 10-treatment EA Program
The change in neuropathic pain after a 10-treatment EA program in subjects with CIPN, was assessed by the Brief Pain Inventory Short Form (BPI-SF) at Baseline, 2-Week Post EA, and 3 Month Post EA. Used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. Pain and interference are rated on a 10-point scale (0 = no pain/interference and 10 = pain as bad as you can imagine/complete interference). Higher scores mean worse outcomes.
Measured: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)
Change in Quality of Life After a 10-treatment EA Program
Assessed by the Total Outcome Index (TOI), including the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) subscale at Baseline, 2-Week Post EA, and 3 Month Post EA. The Total Outcome Index (TOI) ranges from 0 to 100, with higher scores consistently indicating better outcomes. Items are rated on a 0-4 Likert scale and negatively worded items are reverse scored so that higher values always reflect better health status. The neurotoxicity subscale score is calculated by summing the scored responses to the neurotoxicity items (with standard prorating if some items are missing), and the TOI is calculated by summing the Physical Well-Being, Functional Well-Being, and Neurotoxicity subscale scores. Lower scores on either measure indicate worse symptoms or functioning, while higher scores reflect improvement or better quality of life related to neurotoxicity.
Measured: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start29 Aug 2019
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455409
- Sponsor's protocol ID
- PRO00020813 (HMCC-BR18-002)
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Piccolo J, Kolesar JM. Prevention and treatment of chemotherapy-induced peripheral neuropathy. Am J Health Syst Pharm. 2014 Jan 1;71(1):19-25. doi: 10.2146/ajhp130126.
PubMed 24352178Hershman 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 24733808Balayssac D, Ferrier J, Descoeur J, Ling B, Pezet D, Eschalier A, Authier N. Chemotherapy-induced peripheral neuropathies: from clinical relevance to preclinical evidence. Expert Opin Drug Saf. 2011 May;10(3):407-17. doi: 10.1517/14740338.2011.543417. Epub 2011 Jan 6.
PubMed 21210753Lichtman SM, Hurria A, Cirrincione CT, Seidman AD, Winer E, Hudis C, Cohen HJ, Muss HB; Cancer and Leukemia Group B. Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840. Ann Oncol. 2012 Mar;23(3):632-638. doi: 10.1093/annonc/mdr297. Epub 2011 Jun 21.
PubMed 21693770Seretny 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 25261162Smith 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 23549581Able SL, Cui Z, Shen W. Duloxetine treatment adherence across mental health and chronic pain conditions. Clinicoecon Outcomes Res. 2014 Feb 11;6:75-81. doi: 10.2147/CEOR.S52950. eCollection 2014.
PubMed 24596469Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol. 2008 Aug;85(4):355-75. doi: 10.1016/j.pneurobio.2008.05.004. Epub 2008 Jun 5.
PubMed 18582529Jeong HJ, Kim BS, Oh JG, Kim KS, Kim HM. Regulatory effect of cytokine production in asthma patients by SOOJI CHIM (Koryo Hand Acupuncture Therapy). Immunopharmacol Immunotoxicol. 2002 May;24(2):265-74. doi: 10.1081/iph-120003759.
PubMed 12066852Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediators Inflamm. 2003 Apr;12(2):59-69. doi: 10.1080/0962935031000114943.
PubMed 12775355Garrow AP, Xing M, Vere J, Verrall B, Wang L, Jude EB. Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT. Acupunct Med. 2014 Jun;32(3):242-9. doi: 10.1136/acupmed-2013-010495. Epub 2014 Mar 21.
PubMed 24657491Zhang C, Ma YX, Yan Y. Clinical effects of acupuncture for diabetic peripheral neuropathy. J Tradit Chin Med. 2010 Mar;30(1):13-4. doi: 10.1016/s0254-6272(10)60003-9.
PubMed 20397454Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x.
PubMed 17355547Galantino ML, Eke-Okoro ST, Findley TW, Condoluci D. Use of noninvasive electroacupuncture for the treatment of HIV-related peripheral neuropathy: a pilot study. J Altern Complement Med. 1999 Apr;5(2):135-42. doi: 10.1089/acm.1999.5.135.
PubMed 10328635Beal MW, Nield-Anderson L. Acupuncture for symptom relief in HIV-positive adults: lessons learned from a pilot study. Altern Ther Health Med. 2000 Sep;6(5):33-42.
PubMed 10979160
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Pilot Study of the Feasibility and Efficacy of Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07455409
- Acronym / sponsor ID
- PRO00020813 (HMCC-BR18-002)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN). The Investigators hypothesize that EA will be a feasible and effective therapy for CIPN.
Detailed description
This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm pilot study assessing the feasibility and efficacy of EA in 20 subjects with CIPN. The primary objective is to determine the feasibility of a 10-treatment EA program in subjects with CIPN. Feasibility will be defined as ≥15 patients completing ≥8 EA treatments. Secondary objectives include change in neuropathic pain and quality of life before and after EA treatment. An exploratory correlative analysis of mechanistic biomarkers will also be performed.
| Arm | Type | Receives |
|---|---|---|
| Electro-Acupuncture (EA) | Experimental | Device: Electro-acupunctureEA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥18 years
- Received curative-intent chemotherapy (i.e., paclitaxel, docetaxel, nab-paclitaxel, carboplatin, oxaliplatin, vinorelbine, ixabepilone, or vincristine) ≥3 months prior to the start of EA treatment
- Persistent Grade ≥2 peripheral neuropathy in the fingers or toes according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
- Eastern Cooperative Oncology Group performance status of ≤2 (see Section 13.3)
- Willing and able to provide written informed consent for the study.
Key exclusion criteria (9 listed)
- Documented medical history of neuropathy resulting from nerve compression (e.g., carpal tunnel syndrome, radiculopathy, or spinal stenosis)
- Severe coagulopathy or bleeding disorder, per the treating physician's discretion
- Presence of cellulitis or other skin infection or condition that would preclude placement of acupuncture needles into the hands or feet
- Diabetes unless Hgb A1c <7.5%
- Unstable cardiac disease
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 |
|---|---|---|
| Electro-acupunctureElectro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles. | Device | Electro-Acupuncture (EA) |
Primary outcome
Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program
Time frame: 5 Months
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
2 secondary outcomes
Change in Neuropathic Pain After a 10-treatment EA Program
Time frame: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)
Change in Quality of Life After a 10-treatment EA Program
Time frame: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24352178Piccolo J, Kolesar JM. Prevention and treatment of chemotherapy-induced peripheral neuropathy. Am J Health Syst Pharm. 2014 Jan 1;71(1):19-25. doi: 10.2146/ajhp130126.
- Background: PubMed 24733808Hershman 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.
- Background: PubMed 21210753Balayssac D, Ferrier J, Descoeur J, Ling B, Pezet D, Eschalier A, Authier N. Chemotherapy-induced peripheral neuropathies: from clinical relevance to preclinical evidence. Expert Opin Drug Saf. 2011 May;10(3):407-17. doi: 10.1517/14740338.2011.543417. Epub 2011 Jan 6.
- Background: PubMed 21693770Lichtman SM, Hurria A, Cirrincione CT, Seidman AD, Winer E, Hudis C, Cohen HJ, Muss HB; Cancer and Leukemia Group B. Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840. Ann Oncol. 2012 Mar;23(3):632-638. doi: 10.1093/annonc/mdr297. Epub 2011 Jun 21.
- Background: PubMed 25261162Seretny 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.
- Background: PubMed 23549581Smith 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.
- Background: PubMed 24596469Able SL, Cui Z, Shen W. Duloxetine treatment adherence across mental health and chronic pain conditions. Clinicoecon Outcomes Res. 2014 Feb 11;6:75-81. doi: 10.2147/CEOR.S52950. eCollection 2014.
- Background: PubMed 18582529Zhao ZQ. Neural mechanism underlying acupuncture analgesia. Prog Neurobiol. 2008 Aug;85(4):355-75. doi: 10.1016/j.pneurobio.2008.05.004. Epub 2008 Jun 5.
- Background: PubMed 12066852Jeong HJ, Kim BS, Oh JG, Kim KS, Kim HM. Regulatory effect of cytokine production in asthma patients by SOOJI CHIM (Koryo Hand Acupuncture Therapy). Immunopharmacol Immunotoxicol. 2002 May;24(2):265-74. doi: 10.1081/iph-120003759.
- Background: PubMed 12775355Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediators Inflamm. 2003 Apr;12(2):59-69. doi: 10.1080/0962935031000114943.
- Background: PubMed 24657491Garrow AP, Xing M, Vere J, Verrall B, Wang L, Jude EB. Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT. Acupunct Med. 2014 Jun;32(3):242-9. doi: 10.1136/acupmed-2013-010495. Epub 2014 Mar 21.
- Background: PubMed 20397454Zhang C, Ma YX, Yan Y. Clinical effects of acupuncture for diabetic peripheral neuropathy. J Tradit Chin Med. 2010 Mar;30(1):13-4. doi: 10.1016/s0254-6272(10)60003-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-acupuncture in people with Chemotherapy-induced Peripheral Neuropathy, run by The Methodist Hospital Research Institute 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 9 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 1 May 2026. 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?
Yes. Results are posted in the registry (first posted 1 May 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?
Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program (time frame: 5 Months). 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 NCT07455409, which also lists 22 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 1 May 2026.