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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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