A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients
Information gained from this clinical trial will provide insight into the efficacy and
mechanism of acupuncture in reducing Bortezomib-induced Peripheral Neuropathy (BIPN) in
multiple myeloma patients. It will examine the effect of acupuncture on serum
proinflammatory cytokine and β-endorphin levels to further understand the mechanism of
acupuncture on a molecular level. This study is the first clinical trial studying the effect
of acupuncture on treating BIPN. It is also the first study to explore the mechanism of
acupuncture through frequent small amount of blood draws at six time points to detect
changes in proinflammatory cytokines and β-endorphins. It has the potential to identify a
minimal risk non-pharmacological intervention to alleviate BIPN symptoms, and to
significantly improve our understanding of the mechanism of acupuncture.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
To determine the response rate, effectiveness and safety of acupuncture in alleviating neuropathic symptoms when treating patients with moderate to severe Bortezomib-induced Peripheral Neuropathy (BIPN).
Response is defined as the average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks as compared to baseline. Effect is defined as as the average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment.
Ting Bao, MD, DABMA
University of Maryland Marlene & Stewart Greenebaum Cancer Center
United States: Institutional Review Board
|University of Maryland Marlene & Stewart Greenebaum Cancer Center||Baltimore, Maryland 21201|