Peripheral NeuropathyNCT02831114
Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy
A study testing Acupuncture in people with Peripheral Neuropathy, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the global use of antidepressants and anticonvulsants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jan 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary invasive carcinoma of the breast (stage I, II, or III)
- Completed active chemotherapeutic with taxane therapy (taxotere, Taxol, Abraxane) within the last 24 months
- Established diagnosis of motor and sensory neuropathy greater or equal to 2 according to the CTCAE v 4.03 scale in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica
- Read, understand, and speak English
Who cannot join
- Currently undergoing active treatment with chemotherapy (not including TKI's or other targeted therapy)
- Any acupuncture treatment for any indication within the 30 days of enrollment
- Cardiac Pacemaker
- Deformities that interfere with accurate acupuncture point locations
- Local infection at or near the acupuncture site
- Pregnant or currently lactating
- Medical History of chronic alcohol use
- Mental incapacitation or significant emotional or psychological disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship
Greenville, South Carolina, 29605
About this study
Official title: Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy (TIPN)
Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the global use of antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus; however, few studies have evaluated acupuncture as a viable treatment for taxane induced peripheral neuropathy. This study will enroll female breast cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences the mechanisms underlying resolution of TIPN. This would provide critical validation of acupuncture and increase potential for other forms of chemotherapy induced peripheral neuropathy.
Read the detailed description
Taxane induced peripheral neuropathy (TIPN) affects many female breast cancer survivors treated with taxane chemotherapies. This condition can include symptoms ranging from minor loss of sensory function, numbness and mild paresthesia to frank pain including burning or tingling sensation or shooting neuropathic pain. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the use of antidepressants and anticonvulsants, both of which have significant efficacy and safety issues with often little reduction in TIPN. The mechanisms of taxane induced peripheral tissue damage are becoming clearer allowing for the potential to develop specific interventions to resolve pain associated with this class of drug. Acupuncture treatment has been used for symptom improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus; however, few studies have evaluated acupuncture as a viable treatment for taxane induced peripheral neuropathy. Moreover, there has been little research considering the biological effect of acupuncture treatment related to the mechanisms of pain resolution. This study will enroll female breast cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship undergo an acupuncture protocol consisting of traditional acupuncture points used for neuropathic pain. This is a prospective, randomized, controlled trial that will consist of two arms. The two arms will consist of 1) acupuncture plus conventional therapy and 2) conventional therapy only (n= 9 participants in each arm). Arm 1 will receive a traditional manual acupuncture protocol twice a week for 6 weeks and once a week for 6 weeks in conjunction with standard of care treatment. Arm 2 will receive standard of care treatment only; acupuncture will be offered to these individuals after a 12 week waitlist. The 18 participants will start an individualized 12 week study schedule and will be recruited over a 4 month time period. This study will assess severity of pain, inflammatory biomarkers, and circulating levels of mitochondrial DNA at baseline, 6 weeks, and 12 weeks for both arms through questionnaires and blood tests. Results of the study will further clarify acupuncture's role as a therapeutic modality for managing pain induced by TIPN while providing evidence that could help unlock a better understanding of its actions.
- Conditions
- Peripheral Neuropathy
- Being tested
- 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.
AcupunctureOther
Acupuncture uses tiny needles to promote blood flow, nervous system signaling, and brings the body back into homeostasis which the state of optimum functioning. Treatment for taxane induced peripheral neuropathy will consist of traditional acupuncture and will use points located in the foot (SP 3, ST 41, LR 3, K 3, GB 41), knee (SP 9, ST 36, K 10, GB 34), and arm (LI 11). Participants will continue to take their conventional therapy. Each acupuncture treatment will take place at Oriental Medicine Associates with trained acupuncturist, William Hendry. Each session should last about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The nine participants in the intervention arm will receive 18 acupuncture treatments over the course of 12 weeks (2 treatments per week for 6 weeks and 1 treatment per week for 6 weeks). They will undergo assessments at baseline, 6 weeks, and 12 weeks through the use of questionnaires and blood tests. The participants will also be allowed to continue their conventional therapy for TIPN. Receives: Other: Acupuncture |
| Control | No intervention | The nine participants in this arm will undergo the same assessments as the intervention arm at baseline, 6 weeks, and 12 weeks. They will not receive any acupuncture treatments during this time, but will be allowed to continue their conventional therapy. The control arm will be offered the same 18 acupuncture treatments after a wait of at least 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in taxane induced peripheral neuropathy symptoms measured by the Patients' Global Impression of Change (PGIC) scale.
All 18 participants will complete the PGIC scale at 6 weeks and 12 weeks. This scale will ask questions about the participants' change in activity limitations, symptoms, emotions, and overall quality of life related to their peripheral neuropathy since the beginning of treatment.
Measured: 12 Weeks
Evaluate the mechanism of acupuncture as a treatment of TIPN through quantification of inflammatory biomarkers and circulation levels of mitochondrial DNA (mtDNA)
Approximately 8ml of blood will be collected from each participant at baseline, 6 weeks, and 12 weeks. The samples will be collected in purple top BD vacutainers.
Measured: 12 Weeks
Secondary outcomes (3)
Change in quality of life using the FACT/GOG-NTX questionnaire
Participants will complete the FACT/GOG-NTX questionnaire at baseline, 6 weeks, and 12 weeks. The questionnaire includes questions about the participants' physical, social/family, emotional, and functional well-being.
Measured: 12 Weeks
Evaluate if neuropathic mechanisms are contributing to pain measured by the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
Participants will complete the LANSS Pain Scale at baseline, 6 weeks, and 12 weeks. This pain scale involves a pain questionnaire and sensory testing to determine to determine if neuropathic mechanisms are still contributing to the participant's pain.
Measured: 12 Weeks
Change in taxane induced peripheral neuropathy related pain measured by the Brief Pain Inventory (BPI).
Participants will complete the BPI at baseline, 6 week, and 12 week. The BPI will ask questions to detail how the pain interferes with the participants' general activity, mood, walking ability, relationships, sleep, and enjoyment of life.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A O'Rourke, MD, Principal investigator, Prisma Health-UpstateRenee J LeClair, PhD, Principal investigator, University of South Carolina School of Medicine, Greenville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831114
- Sponsor's protocol ID
- Pro00038410
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Phillips KD, Skelton WD, Hand GA. Effect of acupuncture administered in a group setting on pain and subjective peripheral neuropathy in persons with human immunodeficiency virus disease. J Altern Complement Med. 2004 Jun;10(3):449-55. doi: 10.1089/1075553041323678.
PubMed 15253848Abuaisha BB, Costanzi JB, Boulton AJ. Acupuncture for the treatment of chronic painful peripheral diabetic neuropathy: a long-term study. Diabetes Res Clin Pract. 1998 Feb;39(2):115-21. doi: 10.1016/s0168-8227(97)00123-x.
PubMed 9597381Zhang 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 20397454Franconi G, Manni L, Schroder S, Marchetti P, Robinson N. A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy. Evid Based Complement Alternat Med. 2013;2013:516916. doi: 10.1155/2013/516916. Epub 2013 Jul 24.
PubMed 23983788Carbonaro M, Escuin D, O'Brate A, Thadani-Mulero M, Giannakakou P. Microtubules regulate hypoxia-inducible factor-1alpha protein trafficking and activity: implications for taxane therapy. J Biol Chem. 2012 Apr 6;287(15):11859-69. doi: 10.1074/jbc.M112.345587. Epub 2012 Feb 24.
PubMed 22367210Hidaka M, Koga T, Kiyota H, Horiguchi T, Shi QW, Hirose K, Uchida T. Relationship between the structures of taxane derivatives and their microtubule polymerization activity. Biosci Biotechnol Biochem. 2012;76(2):349-52. doi: 10.1271/bbb.110797. Epub 2012 Feb 7.
PubMed 22313785Hu JH, Chen T, Zhuang ZH, Kong L, Yu MC, Liu Y, Zang JW, Ge BX. Feedback control of MKP-1 expression by p38. Cell Signal. 2007 Feb;19(2):393-400. doi: 10.1016/j.cellsig.2006.07.010. Epub 2006 Jul 25.
PubMed 16978838Clark IA. The advent of the cytokine storm. Immunol Cell Biol. 2007 Jun;85(4):271-3. doi: 10.1038/sj.icb.7100062. No abstract available.
PubMed 17551531Clark IA. How TNF was recognized as a key mechanism of disease. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):335-43. doi: 10.1016/j.cytogfr.2007.04.002. Epub 2007 May 9.
PubMed 17493863Clark IA, Alleva LM, Budd AC, Cowden WB. Understanding the role of inflammatory cytokines in malaria and related diseases. Travel Med Infect Dis. 2008 Jan-Mar;6(1-2):67-81. doi: 10.1016/j.tmaid.2007.07.002. Epub 2007 Aug 27.
PubMed 18342278Milligan ED, Sloane EM, Langer SJ, Cruz PE, Chacur M, Spataro L, Wieseler-Frank J, Hammack SE, Maier SF, Flotte TR, Forsayeth JR, Leinwand LA, Chavez R, Watkins LR. Controlling neuropathic pain by adeno-associated virus driven production of the anti-inflammatory cytokine, interleukin-10. Mol Pain. 2005 Feb 25;1:9. doi: 10.1186/1744-8069-1-9.
PubMed 15813997Flatters SJL, Bennett GJ. Studies of peripheral sensory nerves in paclitaxel-induced painful peripheral neuropathy: evidence for mitochondrial dysfunction. Pain. 2006 Jun;122(3):245-257. doi: 10.1016/j.pain.2006.01.037. Epub 2006 Mar 13.
PubMed 16530964Kidd JF, Pilkington MF, Schell MJ, Fogarty KE, Skepper JN, Taylor CW, Thorn P. Paclitaxel affects cytosolic calcium signals by opening the mitochondrial permeability transition pore. J Biol Chem. 2002 Feb 22;277(8):6504-10. doi: 10.1074/jbc.M106802200. Epub 2001 Nov 27.
PubMed 11724773Zhang C, Jiang M, Lu A. A traditional Chinese medicine versus Western combination therapy in the treatment of rheumatoid arthritis: two-stage study protocol for a randomized controlled trial. Trials. 2011 Jun 4;12:137. doi: 10.1186/1745-6215-12-137.
PubMed 21639923Bao T, Goloubeva O, Pelser C, Porter N, Primrose J, Hester L, Sadowska M, Lapidus R, Medeiros M, Lao L, Dorsey SG, Badros AZ. A pilot study of acupuncture in treating bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Integr Cancer Ther. 2014 Sep;13(5):396-404. doi: 10.1177/1534735414534729. Epub 2014 May 26.
PubMed 24867959
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy (TIPN)
- ClinicalTrials.gov ID
- NCT02831114
- Acronym / sponsor ID
- Pro00038410
- Conditions
- Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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.
Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the global use of antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus; however, few studies have evaluated acupuncture as a viable treatment for taxane induced peripheral neuropathy. This study will enroll female breast cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences the mechanisms underlying resolution of TIPN. This would provide critical validation of acupuncture and increase potential for other forms of chemotherapy induced peripheral neuropathy.
Detailed description
Taxane induced peripheral neuropathy (TIPN) affects many female breast cancer survivors treated with taxane chemotherapies. This condition can include symptoms ranging from minor loss of sensory function, numbness and mild paresthesia to frank pain including burning or tingling sensation or shooting neuropathic pain. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the use of antidepressants and anticonvulsants, both of which have significant efficacy and safety issues with often little reduction in TIPN. The mechanisms of taxane induced peripheral tissue damage are becoming clearer allowing for the potential to develop specific interventions to resolve pain associated with this class of drug. Acupuncture treatment has been used for symptom improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus; however, few studies have evaluated acupuncture as a viable treatment for taxane induced peripheral neuropathy. Moreover, there has been little research considering the biological effect of acupuncture treatment related to the mechanisms of pain resolution. This study will enroll female breast cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship undergo an acupuncture protocol consisting of traditional acupuncture points used for neuropathic pain. This is a prospective, randomized, controlled trial that will consist of two arms. The two arms will consist of 1) acupuncture plus conventional therapy and 2) conventional therapy only (n= 9 participants in each arm). Arm 1 will receive a traditional manual acupuncture protocol twice a week for 6 weeks and once a week for 6 weeks in conjunction with standard of care treatment. Arm 2 will receive standard of care treatment only; acupuncture will be offered to these individuals after a 12 week waitlist. The 18 participants will start an individualized 12 week study schedule and will be recruited over a 4 month time period. This study will assess severity of pain, inflammatory biomarkers, and circulating levels of mitochondrial DNA at baseline, 6 weeks, and 12 weeks for both arms through questionnaires and blood tests. Results of the study will further clarify acupuncture's role as a therapeutic modality for managing pain induced by TIPN while providing evidence that could help unlock a better understanding of its actions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AcupunctureThe nine participants in the intervention arm will receive 18 acupuncture treatments over the course of 12 weeks (2 treatments per week for 6 weeks and 1 treatment per week for 6 weeks). They will undergo assessments at baseline, 6 weeks, and 12 weeks through the use of questionnaires and blood tests. The participants will also be allowed to continue their conventional therapy for TIPN. |
| Control | No intervention | –The nine participants in this arm will undergo the same assessments as the intervention arm at baseline, 6 weeks, and 12 weeks. They will not receive any acupuncture treatments during this time, but will be allowed to continue their conventional therapy. The control arm will be offered the same 18 acupuncture treatments after a wait of at least 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed primary invasive carcinoma of the breast (stage I, II, or III)
- Completed active chemotherapeutic with taxane therapy (taxotere, Taxol, Abraxane) within the last 24 months
- Established diagnosis of motor and sensory neuropathy greater or equal to 2 according to the CTCAE v 4.03 scale in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica
- Read, understand, and speak English
Key exclusion criteria (8 listed)
- Currently undergoing active treatment with chemotherapy (not including TKI's or other targeted therapy)
- Any acupuncture treatment for any indication within the 30 days of enrollment
- Cardiac Pacemaker
- Deformities that interfere with accurate acupuncture point locations
- Local infection at or near the acupuncture site
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 |
|---|---|---|
| AcupunctureAcupuncture uses tiny needles to promote blood flow, nervous system signaling, and brings the body back into homeostasis which the state of optimum functioning. Treatment for taxane induced peripheral neuropathy will consist of traditional acupuncture and will use points located in the foot (SP 3, ST 41, LR 3, K 3, GB 41), knee (SP 9, ST 36, K 10, GB 34), and arm (LI 11). Participants will continue to take their conventional therapy. Each acupuncture treatment will take place at Oriental Medicine Associates with trained acupuncturist, William Hendry. Each session should last about 30 minutes. | Other | Intervention |
Primary outcome
Change in taxane induced peripheral neuropathy symptoms measured by the Patients' Global Impression of Change (PGIC) scale.
Time frame: 12 Weeks
All 18 participants will complete the PGIC scale at 6 weeks and 12 weeks. This scale will ask questions about the participants' change in activity limitations, symptoms, emotions, and overall quality of life related to their peripheral neuropathy since the beginning of treatment.
Evaluate the mechanism of acupuncture as a treatment of TIPN through quantification of inflammatory biomarkers and circulation levels of mitochondrial DNA (mtDNA)
Time frame: 12 Weeks
Approximately 8ml of blood will be collected from each participant at baseline, 6 weeks, and 12 weeks. The samples will be collected in purple top BD vacutainers.
3 secondary outcomes
Change in quality of life using the FACT/GOG-NTX questionnaire
Time frame: 12 Weeks
Evaluate if neuropathic mechanisms are contributing to pain measured by the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
Time frame: 12 Weeks
Change in taxane induced peripheral neuropathy related pain measured by the Brief Pain Inventory (BPI).
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Background: PubMed 15253848Phillips KD, Skelton WD, Hand GA. Effect of acupuncture administered in a group setting on pain and subjective peripheral neuropathy in persons with human immunodeficiency virus disease. J Altern Complement Med. 2004 Jun;10(3):449-55. doi: 10.1089/1075553041323678.
- Background: PubMed 9597381Abuaisha BB, Costanzi JB, Boulton AJ. Acupuncture for the treatment of chronic painful peripheral diabetic neuropathy: a long-term study. Diabetes Res Clin Pract. 1998 Feb;39(2):115-21. doi: 10.1016/s0168-8227(97)00123-x.
- 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.
- Background: PubMed 23983788Franconi G, Manni L, Schroder S, Marchetti P, Robinson N. A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy. Evid Based Complement Alternat Med. 2013;2013:516916. doi: 10.1155/2013/516916. Epub 2013 Jul 24.
- Background: PubMed 22367210Carbonaro M, Escuin D, O'Brate A, Thadani-Mulero M, Giannakakou P. Microtubules regulate hypoxia-inducible factor-1alpha protein trafficking and activity: implications for taxane therapy. J Biol Chem. 2012 Apr 6;287(15):11859-69. doi: 10.1074/jbc.M112.345587. Epub 2012 Feb 24.
- Background: PubMed 22313785Hidaka M, Koga T, Kiyota H, Horiguchi T, Shi QW, Hirose K, Uchida T. Relationship between the structures of taxane derivatives and their microtubule polymerization activity. Biosci Biotechnol Biochem. 2012;76(2):349-52. doi: 10.1271/bbb.110797. Epub 2012 Feb 7.
- Background: PubMed 16978838Hu JH, Chen T, Zhuang ZH, Kong L, Yu MC, Liu Y, Zang JW, Ge BX. Feedback control of MKP-1 expression by p38. Cell Signal. 2007 Feb;19(2):393-400. doi: 10.1016/j.cellsig.2006.07.010. Epub 2006 Jul 25.
- Background: PubMed 17551531Clark IA. The advent of the cytokine storm. Immunol Cell Biol. 2007 Jun;85(4):271-3. doi: 10.1038/sj.icb.7100062. No abstract available.
- Background: PubMed 17493863Clark IA. How TNF was recognized as a key mechanism of disease. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):335-43. doi: 10.1016/j.cytogfr.2007.04.002. Epub 2007 May 9.
- Background: PubMed 18342278Clark IA, Alleva LM, Budd AC, Cowden WB. Understanding the role of inflammatory cytokines in malaria and related diseases. Travel Med Infect Dis. 2008 Jan-Mar;6(1-2):67-81. doi: 10.1016/j.tmaid.2007.07.002. Epub 2007 Aug 27.
- Background: PubMed 15813997Milligan ED, Sloane EM, Langer SJ, Cruz PE, Chacur M, Spataro L, Wieseler-Frank J, Hammack SE, Maier SF, Flotte TR, Forsayeth JR, Leinwand LA, Chavez R, Watkins LR. Controlling neuropathic pain by adeno-associated virus driven production of the anti-inflammatory cytokine, interleukin-10. Mol Pain. 2005 Feb 25;1:9. doi: 10.1186/1744-8069-1-9.
- Background: PubMed 16530964Flatters SJL, Bennett GJ. Studies of peripheral sensory nerves in paclitaxel-induced painful peripheral neuropathy: evidence for mitochondrial dysfunction. Pain. 2006 Jun;122(3):245-257. doi: 10.1016/j.pain.2006.01.037. Epub 2006 Mar 13.
- 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.
Mark A O'Rourke, MD principal investigator
Prisma Health-Upstate
Renee J LeClair, PhD principal investigator
University of South Carolina School of Medicine, Greenville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Peripheral Neuropathy, run by Prisma Health-Upstate 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 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 taxane induced peripheral neuropathy symptoms measured by the Patients' Global Impression of Change (PGIC) scale. (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831114, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.