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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraepidermal Nerve Fiber (IENF) Density After a 10-treatment EA Program | Measure the change in intraepidermal nerve fiber (IENF) density after a 10-treatment EA program in subjects with CIPN | 5 Months |
| Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Neal Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24352178 | Background | 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. | |
| 24733808 | Background | 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. |
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During the study period, 31 patients with early-stage breast cancer consented onto the trial. Among these, 23 met the eligibility criteria, and 20 of the 23 were enrolled and started treatment. The first patient was consented on 8/29/2019 and the last patient was consented on 4/25/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electro-Acupuncture (EA) | 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. Electro-acupuncture: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
20 eligible female participants underwent baseline assessments and started treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Electro-Acupuncture (EA) | 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. Electro-acupuncture: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The number of patients that completed 8 or more EA sessions. Two subjects discontinued treatments (10%), with one withdrawing after 3 EA sessions due to transportation challenges, and the other ceased participation after 6 sessions, citing difficulty attending multiple appointments due to chronic knee pain | Posted | Count of Participants | Participants | 5 Months |
|
Approximately 11 weeks, from the time of informed consent to 7 days after study intervention ends.
Adverse events were collected at every treatment visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electro-Acupuncture (EA) | 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. Electro-acupuncture: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Infection | Infections and infestations | NCI CTCAE v3.0 | Systematic Assessment | Related to Skin Punch Biopsy, Unrelated to EA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Polly Niravath, M.D. | Houston Methodist Neal Cancer Center | (713) 441-9948 | paniravath@houstonmethodist.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2022 | Mar 6, 2026 | Prot_SAP_000.pdf |
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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.
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| 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. | Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months) |
Measure the changes in serum levels of inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), TNF-α, IL-1, and IL-6 after a 10-treatment EA program in subjects with CIPN. |
| 5 Months |
| 21210753 | Background | Balayssac 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. |
| 21693770 | Background | Lichtman 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. |
| 25261162 | Background | 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. |
| 23549581 | Background | 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. |
| 24596469 | Background | Able 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. |
| 18582529 | Background | Zhao 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. |
| 12066852 | Background | Jeong 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. |
| 12775355 | Background | Zijlstra 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. |
| 24657491 | Background | Garrow 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. |
| 20397454 | Background | Zhang 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. |
| 17355547 | Background | Schroder 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. |
| 10328635 | Background | Galantino 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. |
| 10979160 | Background | Beal 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. |
| 16783284 | Background | Wong R, Sagar S. Acupuncture treatment for chemotherapy-induced peripheral neuropathy--a case series. Acupunct Med. 2006 Jun;24(2):87-91. doi: 10.1136/aim.24.2.87. |
| 21875929 | Background | Donald GK, Tobin I, Stringer J. Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupunct Med. 2011 Sep;29(3):230-3. doi: 10.1136/acupmed.2011.010025. |
| 20578381 | Background | Xu WR, Hua BJ, Hou W, Bao YJ. [Clinical randomized controlled study on acupuncture for treatment of peripheral neuropathy induced by chemotherapeutic drugs]. Zhongguo Zhen Jiu. 2010 Jun;30(6):457-60. Chinese. |
| 27130723 | Background | Wong R, Major P, Sagar S. Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy. Integr Cancer Ther. 2016 Jun;15(2):153-64. doi: 10.1177/1534735415627926. Epub 2016 Apr 29. |
| 24886772 | Background | Garcia MK, Cohen L, Guo Y, Zhou Y, You B, Chiang J, Orlowski RZ, Weber D, Shah J, Alexanian R, Thomas S, Romaguera J, Zhang L, Badillo M, Chen Y, Wei Q, Lee R, Delasalle K, Green V, Wang M. Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: a feasibility study. J Hematol Oncol. 2014 May 9;7:41. doi: 10.1186/1756-8722-7-41. |
| 22146780 | Background | Schroeder S, Meyer-Hamme G, Epplee S. Acupuncture for chemotherapy-induced peripheral neuropathy (CIPN): a pilot study using neurography. Acupunct Med. 2012 Mar;30(1):4-7. doi: 10.1136/acupmed-2011-010034. Epub 2011 Dec 5. |
| 27013473 | Background | Greenlee H, Crew KD, Capodice J, Awad D, Buono D, Shi Z, Jeffres A, Wyse S, Whitman W, Trivedi MS, Kalinsky K, Hershman DL. Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer. Breast Cancer Res Treat. 2016 Apr;156(3):453-464. doi: 10.1007/s10549-016-3759-2. Epub 2016 Mar 25. |
| Participants |
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| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Baseline BPI-SF questionnaires were completed by all 20 patients | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months) |
|
|
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| Secondary | 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. | 20 patients completed the questionnaires | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months) |
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| Other Pre-specified | Change in Intraepidermal Nerve Fiber (IENF) Density After a 10-treatment EA Program | Measure the change in intraepidermal nerve fiber (IENF) density after a 10-treatment EA program in subjects with CIPN | The localized skin biopsy site infections led to the discontinuation of skin biopsies for IENF density quantification | Posted | 5 Months |
|
|
| Other Pre-specified | Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program | Measure the changes in serum levels of inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), TNF-α, IL-1, and IL-6 after a 10-treatment EA program in subjects with CIPN. | The change in serum inflammatory cytokines were measured from baseline to end of treatment. 7 Patients were analyzed for serum inflammatory cytokines. | Posted | Count of Participants | Participants | 5 Months |
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| 0 |
| 20 |
| 0 |
| 20 |
| 6 |
| 20 |
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| Fatigue | General disorders | NCI CTCAE v3.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | NCI CTCAE v3.0 | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| Serum Level Change Unavailable |
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| TNFa |
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| CCL2 |
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| CCL4 |
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| IL-17 |
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| IL-8 |
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| IL-13 |
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| IL-10 |
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| IL-12 |
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| IL-2 |
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| IFN-g |
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| IL-7 |
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