Trial Information

Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients

This is a single-center, pilot (phase IIb), randomized, standard care- and placebo (sham
acupuncture)-controlled clinical trial (N=60) assessing the effects of acupuncture to
prevent chemotherapy dose reduction due to chemotherapy-induced peripheral neuropathy (CIPN)
and to elucidate the mechanism of action. Breast or colorectal cancer patients receiving
neoadjuvant or adjuvant chemotherapy containing neurotoxic agents (taxanes or oxaliplatin)
at the University of Maryland Marlene & Stewart Greenebaum Cancer Center (UMGCC) will be
screened for CIPN. Once these patients develop greater than or equal to National Cancer
Institute-Common Toxicity Criteria (NCI-CTC) grade 2 CIPN, they will be recruited for this
study. Severity of CIPN as defined by NCI-CTC is listed in Appendix A. Patients will be
stratified based on cancer type (breast cancer vs colorectal cancer). The patients will
then be randomly assigned to one of three arms: (A) real acupuncture, (B) sham acupuncture
or (C) standard care. All patients will follow the same chemotherapy dose reduction
algorithm (Appendix B). No concomitant anti-neuropathy medication is allowed. Patients in
the intervention arms will be randomly assigned to undergo weekly real or sham acupuncture
until the end of their chemotherapy. In these two arms, the patient, the patient's medical
oncologist, pharmacist, research nurse, and study coordinator will be blinded to the
treatment assignment. In standard care arm, patients will not receive additional therapy for
CIPN. Their CIPN will be managed according to the standard chemotherapy dose reduction
algorithm. In all arms, chemotherapy dose will be documented during the patient's scheduled
chemotherapy sessions. The chemotherapy relative dose intensity (RDI) will be calculated at
the end of their chemotherapy. Validated patient-reported outcome questionnaires:
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity
(FACT/GOG-Ntx) questionnaire and Neuropathy Pain Scale (NPS), described later, will be used
to assess CIPN severity weekly in all patients until the end of their chemotherapy and at
the 4 week follow up. Nerve conduction study will be performed by a neurologist at baseline
and after chemotherapy is finished. Side effects from real or sham acupuncture will be
recorded weekly. Approximately 4 ml of blood will be drawn from patients before each real
or sham acupuncture treatment, or with routine weekly blood work check (in the standard care
arm), at the end of chemotherapy, and at the 4 week follow up to measure changes in nerve
growth factor and other neurotrophic factors such as brain-derived neurotrophic factor,
neurotrophin-3, the insulin-like growth factors, and vascular endothelial growth factor.
They will be analyzed in the cytokine lab at the University of Maryland School of Medicine
(UMSOM).