A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

Chemotherapy drugs used to treat cancer can cause temporary or permanent damage to the nerves
in the hands and feet, a condition called "chemotherapy-induced peripheral neuropathy". The
most common symptoms of chemotherapy-induced peripheral neuropathy are pain, tingling,
burning or numbness sensation, which can lead to balance problems or trouble using fingers or
pick up/holding things. These symptoms often last months to years after the completion of
chemotherapy. Medications and nutritional supplements can ease the symptoms of
chemotherapy-induced peripheral neuropathy, but many patients continue to experience symptoms
despite these treatments.

Acupuncture is an intervention in which hair-thin, stainless steel needles are shallowly
inserted into specific points on the skin, with the goal of influencing the body's natural
healing system. Acupuncture has been studied in clinical trials in cancer patients and has
been shown to be effective for various conditions including chemotherapy-induced nausea and
vomiting. A few preliminary studies have suggested that acupuncture may help to reduce
symptoms of peripheral neuropathy, but more information is needed about the benefits of
acupuncture in breast cancer patients This study is being done to evaluate the potential
benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in
the hands and feet of women with peripheral neuropathy after completion of chemotherapy for
breast cancer.

This research study will help to determine the benefits of acupuncture for the treatment of
chemotherapy-induced peripheral neuropathy. The study will also look at two different
acupuncture schedules to determine whether patients derive benefits from lower and higher
dose acupuncture treatments.

Inclusion Criteria:

- History of histologically or cytologically proven breast cancer at stage I, II and
III, without evidence of distant metastasis;

- Completed adjuvant taxane-based chemotherapy as single agents or in combination with
platins or HER-2 directed therapy

- Reporting grade 1 or greater of the following symptoms persistently for more than 2
weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia,
hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common
Terminology Criteria for Adverse Events (CTCAE v. 4.03) (Table 1 and the screening
checklist);

- Patients who are currently on stable prescription medications or dietary supplements
for CIPN and still symptomatic as defined above will be allowed to participate in the
study. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline,
duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs;
glutamine, glutathione, vitamin E and vitamin B12;

- Age ≥ 18 years;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

- Adequate hematological function: neutrophil count >1.0 x109/L, platelet count
>50x109/L;

- Signed informed consent.

Exclusion Criteria:

- Patients with any of the following criteria will not be eligible for the study:

- Unstable cardiac disease or myocardial infarction within 6 months prior to study
entry;

- Wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure
disorder;

- History of pre-existing peripheral neuropathy prior to chemotherapy, including
alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, toxic
neuropathy;

- Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or
surgical trauma;

- Pregnancy or potential pregnancy and nursing;

- Active clinically significant uncontrolled infection;

- Prior use of acupuncture for CIPN within 6 months prior to study entry;

- Patients with uncontrolled major psychiatric disorders, such as major depression or
psychosis, will not be eligible for this trial. Patients with a history of depression
or anxiety who are stable on or off psychiatric medications will be eligible.