1068GCC 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 (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN) [ Time Frame: Baseline and 10 weeks ] [ 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. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial.
For the scale range, the higher the score the worse the symptoms and function. No subscales were used.
|Study Start Date:||May 2011|
|Study Completion Date:||December 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.
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|