Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer

PRIMARY OBJECTIVES:

I. To obtain preliminary evidence of the clinical effects of acupuncture compared to usual
care on the change in sensory neuropathic pain as measured by the European Organization of
Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire
(QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 item (20) sensory subscale.

SECONDARY OBJECTIVES:

I. Change in the motor and autonomic neuropathic pain subscores on the EORTC QLQ-CIPN20.

II. Change in patient-reported assessment of numbness and tingling using the 2-item
Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE)
measure.

III. Preventing the escalation of CIPN from grade 1 or 2 to a higher grade. IV. Amount and
intensity of planned chemotherapy relative to completed chemotherapy.

V. Effect on sensory and motor nerve function via nerve conduction studies (NCS) (e.g.
conduction velocity, latency, and amplitude).

VI. Effect on intraepidermal nerve fiber density (IENF) via skin biopsy. VII. Effect on
peripheral nerve swelling via nerve ultrasound (e.g. cross sectional area, CSA).

EXPLORATORY OBJECTIVES:

I. To obtain preliminary evidence on phenotypic differences between African-American and non
African-American (A-A) (i.e., white, Asian, etc.) with regard to presentation of CIPN as well
as response to the intervention.

II. To examine the associations among the peripheral nerve assessment measures (nerve
conduction, peripheral nerve ultrasound, skin biopsy) and of the peripheral nerve assessment
measures with the patient reported outcomes (EORTC QLQ-CIN20, PRO-CTCAE) at baseline, week
12, and for the change from baseline to week 12.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP 1: Participants undergo 8 45-minute acupuncture treatments over 10 weeks.

GROUP 2: Participants receive usual care.

After completion of study treatment, participants are followed up at 12 weeks.

Inclusion Criteria:

- Breast cancer stage I-III

- Currently receiving taxane-based chemotherapy (either adjuvant or neoadjuvant)

- Clinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the
National Cancer Institute (NCI)-CTCAE

- Ability and willingness to understand and sign an informed consent

Exclusion Criteria:

- Self-reported or documented history of pre-existing peripheral neuropathy due to
diabetes, human immunodeficiency virus (HIV), or other conditions

- Unable to provide medical history

- Pregnant

- Unwilling to receive acupuncture or unable to travel for treatments