This phase II trial tests the effect of acupuncture on nerve pain (peripheral neuropathy) caused by taxane chemotherapy in patients with breast cancer. Peripheral neuropathy is a common, potentially painful, debilitating, and dose-limiting side effect from many chemotherapy drugs, including taxane. There currently is no effective treatment or preventative measure for peripheral neuropathy. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. Real acupuncture may help prevent peripheral neuropathy pain from getting worse when compared to placebo (sham) acupuncture in patients with breast cancer undergoing chemotherapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05458284.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Evaluate the effectiveness of real acupuncture versus sham acupuncture in preventing taxane induced peripheral neuropathy (TIPN) progression as measured by the Neuropathic Pain Scale (NPS) in patients with early stage breast cancer who are receiving curative intent weekly taxane containing regimen and who have grade >= 1 TIPN.
SECONDARY OBJECTIVE:
I. Evaluate the effects of real acupuncture versus sham acupuncture on chemotherapy adherence as measured by chemotherapy relative dose intensity (RDI =received chemotherapy dose/planned chemotherapy dose) and TIPN-related chemotherapy discontinuation.
TERTIARY OBJECTIVES:
I. Evaluate quantitative sensory testing (QST) at baseline as a neurobiological marker to predict acupuncture treatment response.
II. Evaluate the effectiveness of real acupuncture versus sham acupuncture in improving TIPN symptoms and health-related quality of life as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity (FACT/GOG-Ntx) subscale, Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN)20, Hospital Anxiety and Depression Scale (HADS), and Patient-Reported Outcomes Measurement Information System (PROMIS) Scale version (v)1.2 - Global Health patient reported outcomes.
OUTLINE:
SCREENING PHASE: Patients receive TIPN screening each week until they develop grade 1 or higher by Common Terminology Criteria for Adverse Events (CTCAE) criteria.
INTERVENTION PHASE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive real acupuncture over 1 hour once a week (QW) until completion of chemotherapy.
ARM B: Patients receive sham acupuncture over 1 hour QW until completion of chemotherapy.
After completion of study treatment, patients are followed up at 4 and 12 weeks.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJun J. Mao
