Clinical trial NCT02831114: Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy
Official title: Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy (TIPN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in taxane induced peripheral neuropathy symptoms measured by the Patients' Global Impression of Change (PGIC) scale.
timeFrame: 12 Weeks
measure: Evaluate the mechanism of acupuncture as a treatment of TIPN through quantification of inflammatory biomarkers and circulation levels of mitochondrial DNA (mtDNA)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in quality of life using the FACT/GOG-NTX questionnaire
timeFrame: 12 Weeks
measure: Evaluate if neuropathic mechanisms are contributing to pain measured by the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
timeFrame: 12 Weeks
measure: Change in taxane induced peripheral neuropathy related pain measured by the Brief Pain Inventory (BPI).
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Mark A O'Rourke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina School of Medicine, Greenville
name: Renee J LeClair, PhD
role: PRINCIPAL_INVESTIGATOR
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