Back to results1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
Primary Purpose
Peripheral Neuropathies, Multiple Myeloma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Neuropathies focused on measuring Acupuncture Therapy, bortezomib-induced peripheral neuropathy
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.
Sites / Locations
- University of Maryland Marlene & Stewart Greenebaum Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
All participants will receive acupuncture treatments over a total of 10 weeks.
Outcomes
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)
The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01541644
First Posted
February 20, 2012
Last Updated
November 5, 2019
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01541644
Brief Title
1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathies, Multiple Myeloma
Keywords
Acupuncture Therapy, bortezomib-induced peripheral neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
All participants will receive acupuncture treatments over a total of 10 weeks.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.
Primary Outcome Measure Information:
Title
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)
Description
The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as 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.
Time Frame
Baseline and 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Bao, MD, DABMA
Organizational Affiliation
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Marlene & Stewart Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
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