Abstract
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of neurotoxic chemotherapy for breast cancer patients. CIPN develops within weeks or months after chemotherapy is initiated and affects 30-40% of breast cancer patients. As a result of severe CIPN, about 8% of breast cancer patients require their chemotherapy dose to be reduced or discontinued, which could detrimentally impact breast cancer related outcomes. Acupuncture is a Traditional Chinese Medicine technique that involves inserting filiform stainless steel needles into pre-defined points on the skin. Previous clinical trials suggest that acupuncture may be an effective treatment to reduce CIPN symptoms with minimal interactions with chemotherapy.
Methods: We are conducting a pilot, randomized, standard care and placebo controlled clinical trial (N = 60) assessing the effects of acupuncture to prevent chemotherapy dose reduction due to CIPN. Breast cancer patients receiving taxane based chemotherapy in the neoadjuvant or adjuvant setting will be screened for development of Grade 2 CIPN by completing a weekly Functional Assessment of Cancer Therapy-Neurotoxicity (FACT-Ntx) questionnaire. If patients develop Grade 2 CIPN during chemotherapy they will be randomized to one of three groups: real acupuncture (N = 20), sham acupuncture (N = 20) or standard of care (N = 20). Patients and investigators will be blinded to the treatment assignments. All patients will complete FACT-Ntx and Neuropathy Pain Scale questionnaires weekly. Patients in the real or sham acupuncture groups will receive weekly real or sham acupuncture treatments. Use of pain medications and acupuncture-related adverse events will be self recorded daily in patient diaries. We will explore changes in serum nerve growth factor and other neurotrophic factors such: as brain-derived neurotrophic factor, neurotrophin-3, insulin-like growth factors, and vascular endothelial growth factor. Blood (4 ml) will be drawn before each real or sham acupuncture treatment, at the end of chemotherapy, and at a 4 week follow up visit.
Statistics: We expect that acupuncture will significantly decrease the number of patients who require dose reduction during a course of chemotherapy, and increase chemotherapy cumulative relative dose intensity. When a sample size in each cohort is 20, a three group Chi-square test with a 0.05 Type I error will have an adequate 85% power to distinguish between these groups of patients when the proportions are characterized by effect size, of 0.187. We expect the following proportions of patients who would require dose reduction in the acupuncture, sham acupuncture and standard care arms to be 0.05, 0.2, and 0.5, respectively. Statistical analysis will be conducted on-intent-to treat basis.
Our specific aims are: to determine the effect of acupuncture on chemotherapy dose reduction, to determine the effect of acupuncture on CIPN during chemotherapy and to explore the mechanisms of acupuncture in treating CIPN. Nine subjects have been consented for screening and one has been randomized. Recruitment is ongoing. Please contact rkirk@umm.edu if interested in the trial.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT3-1-09.
Volume 73, Issue 24 Supplement
