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

This study has been completed.
Information provided by (Responsible Party):
Ting Bao, University of Maryland Identifier:
First received: February 20, 2012
Last updated: February 12, 2016
Last verified: October 2015

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.

Condition Intervention
Peripheral Neuropathies
Multiple Myeloma
Device: Acupuncture

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.

Enrollment: 27
Study Start Date: May 2011
Study Completion Date: December 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
All participants will receive acupuncture treatments over a total of 10 weeks.
Device: Acupuncture
Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01541644

United States, Maryland
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Ting Bao, MD, DABMA University of Maryland Marlene & Stewart Greenebaum Cancer Center
  More Information

Responsible Party: Ting Bao, Assistant Profressor, University of Maryland Identifier: NCT01541644     History of Changes
Other Study ID Numbers: HP-00047788  GCC 1068 
Study First Received: February 20, 2012
Results First Received: April 21, 2015
Last Updated: February 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Acupuncture Therapy
bortezomib-induced peripheral neuropathy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases
Antineoplastic Agents processed this record on October 28, 2016