1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Feb 23, 2012

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented diagnosis of multiple myeloma.
• • Greater than or equal to grade 2 BIPN as defined by the National Cancer Institute - -Common Toxicity Criteria (NCI-CTC) 4.0.
• • BIPN symptoms persist after bortezomib has been discontinued.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
• • Men and women who are ≥ 18 years old
• • The patient is aware of the nature of his or her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
• Exclusion Criteria:
• • Prior acupuncture within the past month.
• • Life expectancy is \< 3 months.
• • Plan to go on experimental drug for multiple myeloma that is known to cause peripheral neuropathy in the next 14 weeks.
• • Concomitant treatment with chemotherapy, unless approval is given by the Principal Investigator.