Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
Patients are asked to be in this study if they have multiple myeloma and are having tingling, numbness and pain from taking bortezomib (velcade®). Patients who have been diagnosed with multiple myeloma often take bortezomib (velcade®).
This research is being done to find out if acupuncture can reduce the nerve pain, tingling, and/or numbness patients experience due to bortezomib (velcade®).
Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can be used to ease nerve pain and tingling, numbness that is caused by bortezomib.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients|
- 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). [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]
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.
- To assess if acupuncture treatment is associated with reduced oral analgesic use in patients with BIPN. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
- To assess if acupuncture treatment is associated with changes in neurologic examination and nerve conduction studies. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
- To explore the mechanisms of acupuncture in treating BIPN by studying the changes in proinflammatory cytokines and beta endorphins. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
- To determine if the study's acupuncture schedule is feasible in treating multiple myeloma patients with BIPN. [ Time Frame: Week 2 ] [ Designated as safety issue: No ]Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
All participants will receive acupuncture treatments over a total of 10 weeks.
Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541644
|United States, Maryland|
|University of Maryland Marlene & Stewart Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Ting Bao, MD, DABMA||University of Maryland Marlene & Stewart Greenebaum Cancer Center|