1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Neurology, Hematology |
| Therapuetic Areas: | Hematology, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2011 |
| End Date: | December 2014 |
A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients
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.
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.
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.
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.
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.
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