NCT02831114

Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy

Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy (TIPN)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	Acupuncture	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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2016-07-13
• Last updated: 2018-01-04

Locations

1 site across 1 country: United States