Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

Peripheral neuropathy is a common problem among cancer patients who have received
chemotherapy treatment. Peripheral neuropathy often causes weakness, numbness and pain,
usually in the hands and feet. It can also affect other areas of the body. People with
peripheral neuropathy generally describe the pain as stabbing, burning or tingling.

Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile,
stainless steel needles into the skin at specific points. Research has shown that acupuncture
can reduce symptoms of pain and nausea by altering pain signaling along nerves. The effect of
acupuncture can be enhanced by additional movement of the needles called manual acupuncture,
which involves rotating the needle and moving it up and down. Another type of acupuncture is
called electro-acupuncture, which involves running a low level electrical current between two
needle points. Preliminary studies indicate that acupuncture may also be helpful to treat
chemotherapy related neuropathy. This trial will determine the relative effects of both
manual acupuncture and electro-acupuncture for treating chronic chemotherapy-induced
neuropathy.

Participants will be assigned to one of two groups: 1) manual acupuncture twice a week for 20
treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments
will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while
subjects are on study.

Inclusion Criteria:

- Participants must have the ability to understand English, sign a written informed
consent document, and be willing to follow protocol requirements.

- History of a diagnosis of cancer, verifiable through documentation in a medical
record.

- Participants must have neuropathy ≥1 according to CTCAE v 4.0 scale or a neuropathy
score of >3 on a 0-10 scale despite previous treatment, which may include Neurontin,
Cymbalta and/or Lyrica.

- The participant's previous chemotherapy treatment must have included a taxane
(paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or
carboplatin) and considered the primary cause of the neuropathy by the medical team.

- More than 6 months since last treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.

- Willingness to comply with all study interventions of acupuncture and follow-up
assessments.

Exclusion Criteria:

- Current active treatment with chemotherapy, radiation or surgery in the past 3 months
or planned treatment during this study protocol period. Hormonal therapy is allowed.

- Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or
bortezomib chemotherapy within the past 6 months.

- Local infection at or near the acupuncture site. (Although acupuncture is a minimally
invasive procedure, participants will be excluded if there is an indication of
infection.)

- Physical deformities that could interfere with accurate acupuncture point location.

- Concurrent use of other alternative medicines such as herbal agents and high dose
vitamins and minerals.

- Known coagulopathy or taking heparin (including low molecular weight heparin) at full
anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Participants
on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will
be allowed to participate.

- Platelets < 50 H K/UL in the past 30 days.

- White Blood Cells (WBCs) < 3.0 K/UL or absolute neutrophil count (ANC) <1,500 K/UL) in
the past 30 days.

- Active Central Nervous System (CNS) disease. (The action for acupuncture may be
associated with central nervous system activity, and participants with CNS pathology
may respond differently to treatment than the general population.)

- Implanted electrical device such as cardiac pacemaker, insulin pump, or pain pump.

- Mental incapacitation or significant emotional or psychological disorder that, in the
opinion of the investigators, precludes study entry. (These participants may not be
able to cooperate with this slightly invasive procedure or with the data collection
process.)

- Currently pregnant. (Certain acupuncture applications have been reported to stimulate
uterine contractions.)

- History of diabetic neuropathy, neuropathy related to HIV, or other medical causes of
chronic neuropathy in the baseline assessment including past medical history, any
history of diabetes, alcoholism, and vitamin B.

- Previous acupuncture treatment for any indication within 30 days of enrollment.

- Planned or actual changes in type of medications that could affect symptoms related to
chemotherapy-induced peripheral neuropathy (CIPN). New medications for the treatment
of CIPN are not allowed during the study. Subjects need to be on stable doses of CIPN
medications for 4 weeks.

- Grade III lymphedema or lymphedema considered severe by the treating clinician